[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sudden-cardiac-death\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sudden-cardiac-death":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,50,82,120,157,193,220,242,265,297,323,353,380,410,430,462,487,515,543,587,612,644,676,699,721],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100494895","observational-study-of-cardiac-arrhythmias-during-treatment-with-btk-inhibitors-or-venetoclax-100494895",false,"NCT05724121","Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Currently receiving or planning to receive a BTKi or venetoclax.\n2. Male or female, aged 18 or older\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Ability of subject to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months\n2. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.","ALL","18 Years","110 Years",{"count":20,"type":21},135,"ESTIMATED","OBSERVATIONAL","Background:\n\nBruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart.\n\nObjective:\n\nTo identify and monitor the effects of BTKi on the heart.\n\nEligibility:\n\nPeople aged 18 and older currently receiving or planning to receive BTKi or venetoclax.\n\nDesign:\n\nParticipants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit.\n\nParticipants will undergo multiple tests:\n\nA physical exam, including collection of blood and saliva.\n\nA test that measures heart activity via stickers placed on the chest.\n\nA test that uses sound waves to capture images of the heart.\n\nAn exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises.\n\nStress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken.\n\nParticipants may wear a device to monitor their heart at home.\n\nParticipants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years.",[25,26,27,28,29,30],"Chronic Lymphocytic Leukemia (CLL)","Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia","Mantle Cell Lymphoma","Sudden Cardiac Death","Cardiac Arrhythmias","Hematologic Malignancies",[32,25,33,34,35,36],"SUDDEN CARDIAC DEATH","Ibrutinib Treatment","Atrial Fibrillation\u002FFlutter","Ventricular Arrhythmias","Natural History","RECRUITING","2026-07-01",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2023-03-01",{"date":45,"type":21},"2027-04-08",{"name":47,"class":48},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":4,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100273922","phase-4-implantable-cardioverter-defibrillator-versus-optimal-medical-therapy-in-patients-with-variant-angina-manifesting-as-aborted-sudden-cardiac-death-100273922","NCT02845531","Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death","VARIANT ICD","Inclusion Criteria:\n\n* Age 18 years or older\n* Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia\n* Diagnosed as variant angina, defined by spontaneous coronary spasm with ST elevation (≥0.1mV) in the coronary angiogram and\u002For documented coronary spasm on ergonovine provocation coronary angiography\n\nExclusion Criteria:\n\n* Significant (\\>50%) coronary artery stenosis on coronary angiography\n* Organic heart disease known to be associated with sudden cardiac arrest.\n\n  * Heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction \\\u003C 35%)\n  * Presence of LV akinesia or aneurysm\n  * Hypertrophic cardiomyopathy\n  * Arrhythmogenic right ventricular dysplasia\n* Chronic Heart Failure New York Heart Association functional class III or IV\n* prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)\n* Prior catheter ablation for ventricular arrhythmia\n* Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)\n* Prior pacemaker or Implantable Cardioverter Defibrillator\n* 2nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker\n* Patients with poor neurologic outcome (defined as cerebral performance category scale ≥3)\n* Life expectancy \\\u003C2 years\n* Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up",{"count":58,"type":21},140,"INTERVENTIONAL",[61],"PHASE4","The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.",[64,28],"Angina Pectoris, Variant",[66,67,68,69,70],"Variant angina","Aborted sudden cardiac death","Implantable Cardioverter Defibrillator","Optimal Medical Therapy","ICD","2026-06-23",{"date":73,"type":41},"2026-06-25",{"date":75,"type":41},"2016-11-29",{"date":77,"type":21},"2031-06",{"name":79,"class":80},"Kee-joon Choi","OTHER",26,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":89,"targetDuration":91,"studyType":22,"phases":4,"briefSummary":92,"conditions":93,"keywords":107,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100558055","national-network-for-cardiovascular-genomics-advancing-cardiovascular-healthcare-for-hereditary-diseases-in-brazils-unified-health-system-through-a-multicenter-registry-100558055","NCT06546137","National Network for Cardiovascular Genomics: Advancing Cardiovascular Healthcare for Hereditary Diseases in Brazil's Unified Health System Through a Multicenter Registry","RENOMICA-Hcor","Inclusion Criteria:\n\n* Clinical diagnosis of a hereditary cardiovascular disease according to current clinical guidelines\n* Agree to receive genetic counseling\n* Sign informed consent form\n* Provide the information required in the case report form\n\nExclusion Criteria:\n\n* Signature absent from informed consent form\n* Inadequate buccal swab (sample may be collected twice)",{"count":90,"type":21},1211,"6 Months","The goal of this observational study is to develop a registry of Brazilian patients with hereditary cardiovascular diseases, combining clinical and genomic data. The main questions it aims to answer are:\n\nWhich genes are most commonly affected? What is the frequency of these genetic alterations in our population? Participants will be interviewed in routine medical care visits and their DNA will be sequenced.",[94,95,96,97,98,99,100,101,102,103,104,105,106,28],"Cardiomyopathy, Hypertrophic","Cardiomyopathy, Dilated","Cardiomyopathy Restrictive","Arrhythmogenic Right Ventricular Dysplasia","Non-Compaction Cardiomyopathy","Familial Hypercholesterolemia","Marfan Syndrome","Ehlers-Danlos Syndrome, Vascular Type","Loeys-Dietz Syndrome","Long QT Syndrome","Short Qt Syndrome","Brugada Syndrome","Catecholaminergic Polymorphic Ventricular Tachycardia",[108,109],"hereditary cardiovascular diseases","whole genome sequencing","2026-05-04",{"date":112,"type":41},"2026-05-08",{"date":114,"type":41},"2025-04-30",{"date":116,"type":21},"2026-08-31",{"name":118,"class":80},"Hospital do Coracao",27,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100289553","mayo-avc-registry-and-biobank-100289553","NCT03049254","Mayo AVC Registry and Biobank","Identification of Novel Genetic Variants and Biomarkers of Disease Progression in Arrhythmogenic Cardiomyopathy","Inclusion Criteria:\n\n* Patients with a diagnosis of a non-MI SCA who survived\n* Patients with a non-MI SCD\n* Patient with a SCA associated with seizures, epilepsy, syncope, drowning and near-drowning, where a cardiomyopathy is suspected\n* Family member of a patient diagnosed with primary cardiomyopathy (including HCM, idiopathic DCM, AVC)\n\nExclusion Criteria:\n\n* Patients with a clear, unambiguous known cause of SCA or SCD such as myocardial infarction or heart failure secondary to ischemic heart disease\n* Significant coronary artery disease (Epicardial coronary artery stenosis \\>50%) which can explain degree of LV dysfunction\n* Those unwilling to provide written consent or assent",true,{"count":129,"type":21},1000,"Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death.\n\nThe Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples.\n\nObjectives of the study:\n\n1. Discover new genes or altered genes (variants) which cause AVC\n2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation)\n3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data.\n4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies",[132,133,134,135,136,28,97,137,138,139,140,141,142,143,144,145,146],"Arrhythmogenic Right Ventricular Cardiomyopathy","Cardiomyopathies","Heart Diseases","Cardiovascular Diseases","Sudden Cardiac Arrest","Arrhythmogenic Ventricular Cardiomyopathy","Familial Dilated Cardiomyopathy","Cardiovascular Abnormalities","Sarcoidosis","Cardiac Arrhythmia","Cardiac Sarcoidosis","Myocarditis","Inflammatory Cardiomyopathy","Ventricular Tachycardia","Right Ventricular Outflow Tract Ventricular Tachycardia","2026-04-22",{"date":149,"type":41},"2026-04-27",{"date":151,"type":41},"2018-02-09",{"date":153,"type":21},"2027-03",{"name":155,"class":80},"Mayo Clinic",2,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":16,"minAge":165,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":59,"phases":168,"briefSummary":170,"conditions":171,"keywords":181,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":49},"100570323","speed-up-the-diagnosis-and-evaluation-of-anomalous-coronary-artery-from-the-aorta-100570323","NCT06705751","Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta","SMART: Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta.","SMART","Inclusion Criteria:\n\n* Adult and pediatric patients (age \\> 6 years) with anomalous coronary origin from the aorta (AAOCA).\n* Patients in spontaneous sinus rhythm.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients with acute and chronic inflammatory conditions such as chronic liver disease, chronic kidney failure (creatinine \\> 1.5 mg\u002Fdl), and thyroid disorders.\n* Patients with arrhythmias, absence of sinus rhythm.\n* Contraindications to autonomic testing.\n* Patients with a known allergy to materials in recording devices.\n* Female patients who are pregnant.","6 Years",{"count":167,"type":21},38,[169],"NA","Anomalous aortic origin of the coronary arteries (AAOCA) is a rare congenital disease and one of the leading causes of sudden cardiac deaths (SCD) in young athletes but also has a lethal presentation in adult age with myocardial infarction, even if not related to obstructive coronary arteries. Unfortunately, diagnostic imaging techniques, invasive assessment, and provocative stress tests have shown low sensitivity and specificity in detecting inducible ischemia, and a multimodality assessment is then necessary.\n\nInnovative tools have been developed in the medical field using computer-based simulation, 3-dimensional reconstruction, machine learning, and artificial intelligence (AI). With the application of such new technologies, we aim to fill the gap of knowledge and the diagnostic limitation regarding risk stratification for most subjects with AAOCA.\n\nThis work seeks to enhance, fasten, and personalize the clinical diagnosis of AAOCA by integrating anatomical measurements, clinical data, and biomechanical patient-specific features. The SMART study will set a system to automatically segment and classify coronary arteries with AAOCA from computerized tomography angiography (CTA) by artificial intelligence (AI). Segmentation will feed a 3D model of the aortic root and coronary artery for biomechanical assessment through finite element analysis (FEA). This will allow us to assess the location of possible coronary artery compression under an effort condition. These in-silico results, the anatomical features measured by AI, and the clinical data will be integrated into a risk model to estimate the hazard risk of adverse events such as SCD or myocardial infarction. This workflow will be framed in an IT system to allow a web-based remote diagnostic service.\n\nThanks to the proposed multidisciplinary approach, SMART aims to overcome the current diagnostic limitations related to the reduced ability of functional stress tests to detect ischemia. Potentially helping in patient-specific risk stratification, SMART is also thought to provide a way to get a first diagnostic indication about AAOCA being accessible from any hospital, fostering the diffusion of peripheral territorial support to the diagnosis and treatment of such rare disease.",[172,173,174,175,176,177,178,28,179,180],"AAOCA","ACAOS","Anomalous Aortic Origin of the Coronary Artery (AAOCA)","Anomalous Coronary Artery Arising From the Opposite Sinus","Anomalous Coronary Artery Origin","Anomalous Coronary Artery With Aortic Origin and Course Between the Great Arteries","Coronary Anomaly","Myocardial Ischemia","Myocardial Ischemia, Angina Pectoris",[172,182,183,173],"CT","IMAGE SEGMENTATION","2026-04-10",{"date":186,"type":41},"2026-04-15",{"date":188,"type":41},"2024-09-12",{"date":190,"type":21},"2027-02",{"name":192,"class":80},"IRCCS Policlinico S. Donato",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":59,"phases":201,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":216,"leadSponsor":218,"locationsCount":49},"100633500","digital-medical-twin-for-the-prediction-of-arrhythmic-sudden-cardiac-death-after-a-myocardial-infarction-100633500","NCT07527494","Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction","TWIN-SCD STEMI","Inclusion Criteria:\n\n* History of ST-segment elevation myocardial infarction (STEMI) in the last 6 months\n* Signed informed consent\n* Affiliated to or beneficiary of a health insurance\n\nExclusion Criteria:\n\n* Renal failure (Creatinine clearance \\\u003C30 mL\u002Fmin), or a systemic illness likely to limit survival to \\\u003C1 year\n* Women who are pregnant, lactating, or who are planning to become pregnant within 2 years following her inclusion\n* Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent\n* Participant under legal protection",{"count":129,"type":21},[169],"TWIN-SCD STEMI is a multicentric prospective, non-randomized pilot study designed to establish a multiparametric model for predicting life-threatening ventricular arrhythmias in patients experiencing their first myocardial infarction. The primary objective of the study is to develop an algorithm with superior predictive performance (sensitivity and specificity) compared to the currently used criterion for the implantation of a cardiac defibrillator, which is a left ventricular ejection fraction (LVEF) of less than 35%.",[28,204],"Myocardial Infarction",[206,207,208,209,210],"Sudden cardiac death","Myocardial infarction","Prediction","Multiparametric model","Ventricular Arrhythmia","NOT_YET_RECRUITING","2026-04-07",{"date":214,"type":41},"2026-04-14",{"date":186,"type":21},{"date":217,"type":21},"2034-12-31",{"name":219,"class":80},"University Hospital, Bordeaux",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":228,"studyType":22,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":49},"100581952","early-evaluation-of-exosome-multiomics-and-clinical-prognosis-in-patients-with-sudden-death-100581952","NCT06856993","Early Evaluation of Exosome Multiomics and Clinical Prognosis in Patients With Sudden Death","Inclusion Criteria:\n\n* The death event happens suddenly.\n* Age ≥ 18 years\n* The patient had obvious clinical symptoms 24 hours before treatment\n* Life expectancy exceeds 3 days\n* Proxy of patients signs the informed consent form\n* Comply with ACS diagnostic indicators recommended by ACC \u002F AHA guidelines in 2016\n\nExclusion Criteria:\n\n* Death caused by accident, such as trauma, poisoning, etc.\n* Death from accidental or intentional overdose\n* Death from asphyxia\n* Death is caused by chronic disease or terminal illness\n* The patient died naturally\n* Has participated in other clinical studies\n* Immediate family members give up continuing treatment",{"count":227,"type":21},300,"3 Months","Acute coronary syndrome (ACS) is one of the main causes of death. Worldwide, tens of millions of patients are hospitalized for coronary heart disease and ACS every year. ACS may show acute myocardial infarction, unstable angina pectoris, and even induce early arrhythmia, leading to sudden death. Sudden cardiac death (SCD) has a strong correlation with ACS. Data from clinical and autopsy studies and death certificates show that 62-85% of patients with out of hospital SCD have a history of ACS, 10% have other cardiac structural abnormalities, and 5% have no cardiac structural abnormalities. An SCD surveillance study from Ireland concluded that most cases occurred in families, and the successful recovery of SCD was mainly related to ventricular fibrillation with arrhythmia. At present, there are few reports on the clinical and prognosis of ACS in China, and there is no guideline or consensus on the prevention and treatment of ACS patients. Known domestic research results show that the proportion of male, overweight \u002F obese, smokers in young ACS patients is higher than that in the elderly group, while the proportion of patients with hypertension, diabetes and cerebrovascular diseases is less than that of the elderly group. The levels of TC, TG, LDL-C and UA and the proportion of low HDL-C in young ACS patients were higher than those in elderly patients; The diagnosis of STEMI was the highest in the young ACS group, while the diagnosis of unstable angina pectoris was the most common in the elderly ACS group. The clinical manifestations of ACS vary greatly. 3% \\~ 5% of patients who exclude ACS only through myocardial markers, clinical blood transfusion and ECG still have myocardial infarction (MI). For the emergency department, early prediction of the risk of SCD in ACS patients and timely and accurate screening of high-risk patients are very important.",[28,231,232],"Exosome Multiomics","Clinical Prognosis","2026-04-06",{"date":235,"type":41},"2026-04-08",{"date":237,"type":41},"2021-12-22",{"date":239,"type":21},"2027-12-31",{"name":241,"class":80},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":59,"phases":251,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100490398","prevention-of-sudden-cardiac-death-after-myocardial-infarction-by-defibrillator-implantation-100490398","NCT05665608","Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation","PROFID EHRA","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Naïve to implantation of any pacemaker or defibrillator\n3. Documented history of MI either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI) at least 3 months prior to enrolment.\n4. Symptomatic heart failure with New York Heart Association (NYHA) class II or III.\n5. On OMT for at least 3 months prior to enrolment.\n6. LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging \\[MRI\\] at least 3 months after MI).\n7. Signed informed consent.\n\nInclusion criterion I3 defines myocardial infarction according to the 2018 ESC\u002FACC\u002FAHA\u002FWHF Fourth Universal Definition of myocardial infarction\n\nExclusion Criteria:\n\n1. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.\n2. Ventricular tachycardia induced in an electrophysiologic study.\n3. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.\n4. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)\n5. Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).\n6. Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.\n7. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.\n8. On the waiting list for heart transplantation.\n\n   Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachy-cardia has to be assessed according to the 2022 ESC Guidelines for the management of patients with ven-tricular arrhythmias and the prevention of SCD.\n9. Any known disease that limits life expectancy to less than 1 year.\n10. Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.\n11. Previous participation in PROFID EHRA.\n\nParallel participation in sub-studies connected to this trial is permitted as well as in purely observational studies without any pre-defined intervention.",{"count":250,"type":21},3595,[169],"Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative.\n\nOBJECTIVE:\n\nTo demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.",[28,204],[68,28,204],"2026-03-31",{"date":257,"type":41},"2026-04-01",{"date":259,"type":41},"2023-11-16",{"date":261,"type":21},"2027-11-30",{"name":263,"class":80},"Charite University, Berlin, Germany",86,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":127,"sex":16,"minAge":273,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":296},"100507694","ai-powered-ecg-analysis-using-willem-software-in-high-risk-cardiac-patients-willem-100507694","NCT05890716","AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)","Evaluation of Electrocardiographic Data From High-risk Cardiac Patients Using Willem™ Cardiologist-level Artificial Intelligence Software. WILLEM Trial.","WILLEM","Inclusion Criteria:\n\n* Patient presenting relevant cardiac arrhythmias and cardiac patterns (including supraventricular tachycardias, abnormal ECG patterns, ventricular tachycardias, ventricular fibrillation, pulseless electrical activity or asystole among others) that have been recorded with at least one short-term ECG medical device according to guidelines with ≥1 signal-channel.\n* Patient with suspected or diagnosed acute\u002Fchronic cardiac diseases (including patients with heart failure, patients with history of cardiac arrhythmias, patients with probable coronary artery diseases, patients with cardiomyopathies, patients with pacemakers or implantable cardioverter-defibrillators (ICD), patients with indication of pacemaker or ICD in current or short-term phase, patients participating in other interventional clinical investigation, patients with hemodynamic instability or acute coronary syndromes, pregnant patients, patients with cancer and chemotherapy, patients with life-expectancy lower than 24 months, patients with in or out-of-hospital cardiac arrest with ventricular fibrillation as first documented rhythm).\n* At least one ECG tracing that can be exported in raw data.\n* Signed informed consent. Patients unable to consent, it will be requested to an authorized relative.\n\nExclusion Criteria:\n\n* Unwillingness or inability to sign study written informed consent.\n* Unavailable or suboptimal quality of the electrocardiographic signal in raw data.","4 Years",{"count":275,"type":21},5342,"WILLEM is a multi-center, prospective and retrospective cohort study.\n\nThe study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal cardiac patterns. The main questions it aims to answer are:\n\n1. A new AI-powered ECG analysis platform can automatice the classification and prediction of cardiac arrhythmic episodes at a cardiologist level.\n2. This AI-powered ECG analysis can delay or even avoid harmful therapies and severe cardiac adverse events such as sudden death.\n\nThe prerequisites for inclusion of patients will be the availability of at least one ECG record in raw data, along with patient clinical data and evolution data after more than 1-year follow-up.\n\nCardiac electrical signals from multiple medical devices will be collected by cardiology experts after obtaining the informed consent. Every cardiac electrical signal from every subject will be reviewed by a board-certified cardiologist to label the arrhythmias and patterns recorded in those tracings. In order to obtain tracings of relevant information, \\>95% of the subjects enrolled will have rhythm disorders or abnormal ECG's patterns at the time of enrollment.",[133,278,29,28],"Cardiac Arrest",[280,281,282,283,284,285],"Artificial intelligence","Cardiac arrhythmias","Heart disease","Cardiac electrical signals","Electrocardiogram","Electrogram","2026-03-30",{"date":288,"type":41},"2026-04-03",{"date":290,"type":41},"2023-04-04",{"date":292,"type":21},"2026-11",{"name":294,"class":295},"Idoven 1903 S.L.","INDUSTRY",14,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":49},"100629575","skeletal-muscle-multi-omics-analysis-and-risk-tailoring-in-sudden-cardiac-death-100629575","NCT07476456","Skeletal Muscle Multi-omics Analysis and Risk Tailoring in Sudden Cardiac Death","Development and Implementation of an Artificial Intelligence-Driven Multimodal Skeletal Muscle Feature Fusion Model for Risk Prediction of Sudden Cardiac Death in Patients With Implantable Cardioverter-Defibrillators: The SMART-SCD Study.","SMART-SCD","Inclusion Criteria:\n\n* Undergoing first-time ICD implantation (including cardiac resynchronization therapy defibrillator, CRT-D implantation);\n* Completed multi-dimensional sarcopenia assessment at baseline;\n* Willing to receive prospective follow-up and signed the informed consent form (ICF)\n\nExclusion Criteria:\n\n* History of valvular heart disease (e.g., mitral stenosis, history of heart valve replacement or valvuloplasty, etc.);\n* Implanted ICD type is subcutaneous ICD (S-ICD) or extra-vascular ICD (EV-ICD);\n* Concomitant comorbidities affecting muscle metabolism, such as malignant tumors, severe liver or kidney disease, etc.",{"count":306,"type":21},421,"This study is designed as a prospective, single-center, observational cohort study (the SMART-SCD Study, full name: Skeletal Muscle Multi-omics Analysis and Risk Tailoring in Sudden Cardiac Death), which enrolls high-risk populations meeting the criteria for implantable cardioverter defibrillator (ICD) implantation.\n\nThe research focuses on the mechanistic association between skeletal muscle metabolic disorders and ventricular arrhythmia (VA) as well as sudden cardiac death (SCD), and aims to construct a \"muscle-heart crosstalk\" risk early warning system through integration of multimodal skeletal muscle data. We will systematically collect the following data:\n\nBaseline handgrip strength measurement (Biomi-h500+X5); Functional diagnosis and phenotyping of sarcopenia conducted via the InBody 270 body composition analyzer; Non-contrast chest and abdominal computed tomography (CT) images (to extract novel imaging phenotypes including skeletal muscle density at the T12 vertebra level, intermuscular adipose tissue, subcutaneous adipose tissue, etc.); Serum biomarkers (GDF-8, Irisin, IL-6); Metabolomics data of skeletal muscle tissue from the ICD pocket (lipid\u002Fenergy metabolism profiles detected via the UPLC-QTOF\u002FMS platform); Ambulatory electrocardiographic data. All treatment and intervention regimens for patients will be independently formulated by clinicians in accordance with clinical guidelines, and the study itself does not involve any intervention measures. Prospective follow-up will be conducted at 3\u002F6\u002F12 months after ICD implantation. The primary endpoint is composite ventricular arrhythmia events (including SCD, appropriate ICD therapy documented by the device, and hemodynamically unstable ventricular tachycardia\u002Fventricular fibrillation), and the secondary endpoint is all-cause mortality.\n\nThrough the above prospective cohort study, we will integrate multimodal data including novel CT imaging phenotypes of skeletal muscle, metabolomics profiles and functional phenotyping of sarcopenia using artificial intelligence techniques, so as to construct a precision prediction model for SCD, screen novel CT imaging phenotypes of sarcopenia and myogenic metabolites, and finally establish a generalizable SCD risk assessment tool and individualized intervention strategies.",[28],[310,311,210,312,206],"Sarcopenia","Skeletal Muscle Metabolism","Multimodal Predictive Model","2026-03-12",{"date":315,"type":41},"2026-03-17",{"date":317,"type":21},"2026-03-16",{"date":319,"type":21},"2028-06-30",{"name":321,"class":322},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":331,"enrollmentInfo":332,"targetDuration":334,"studyType":22,"phases":4,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":352},"100627153","validation-of-sudden-cardiac-arrest-risk-factors-in-patients-with-cad-100627153","NCT07444931","Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD","Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD - CVDLINK Clinical Validation Study.","SCAR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Ability to give informed consent\n* Imaging confirmed diagnosis within the past 12 months (coronary artery angiography or contrast enhanced coronary computed tomography)\n\n  •\\>50% of stenosis and\u002For fractional flow-reserve \\\u003C0.8 verified by selective coronary angiography or by contrast enhanced coronary computed tomography (CT) or type I MI with atherosclerotic origin (despite stenosis percentage)\n* Patients may be recruited during index event visit (out-patient clinic visit, invasive procedure, hospitalization) (or if logistically possible recall patients previously diagnosed within 12 months)\n\nExclusion Criteria:\n\n* Age \\> 75 years of age\n* Clinically significant previously treated valvular heart disease or requiring operative (surgical or endovascular) treatment within following three months\n* Diagnosed severe neurodegenerative disease (ALS, myositis, multiple sclerosis, or Parkinson's disease) or known impaired cognitive function (MMSE \\\u003C23)\n* Known developmental disability impairing legal ability to give written consent\n* Serious\u002Factive malignancy with possibly reduced life expectancy of \\\u003C1 year (estimated by a physician)\n* Inability to give written consent for some other reason\n* Other significant cardiac condition severely linked to the risk of fatal ventricular arrhythmia (for example ARVCD, non-ischemic DCM, HCM or genetic long or short QT syndrome)\n* Other cardiac disease with \\\u003C1 years of life expectancy\n* Do-Not-Resuscitate (DNR) order made due to any reason\n* Previously done or planned cardiac, renal, or liver transplant\n* Participation in another clinical trial where the active treatment","75 Years",{"count":333,"type":21},1500,"1 Year","Long-term sudden cardiac death (abbreviation: SCAR) focuses on improving the predictability of sudden cardiac death (SCD) in patients diagnosed with coronary artery disease. The aim of the study is to determine the predictive value of measurable biological variables (including genetic factors, cardiac electrical activity, biological markers measured from circulation, and coronary artery anatomy) as well as the patients' psychosocial factors in predicting SCDs.\n\nThe purpose of this study is the identification of a subgroup of coronary artery disease patients at sufficiently high risk in whom it may be possible to prevent sudden cardiac arrests and subsequent deaths using implantable cardioverter-defibrillators. The study is intended to establish a clear foundation for future interventional studies targeting high-risk coronary artery disease patients.\n\nThe primary endpoint of the study is SCD\u002Fsudden cardiac arrest (SCA) or a comparable malignant arrhythmic event (i.e., resuscitation). Secondary endpoints include other major cardiovascular events occurring during the follow-up period (such as cerebrovascular events, myocardial infarctions, revascularizations, and new arrhythmias like atrial fibrillation following procedures or after the patient has been discharged following recruitment) or the occurrence and mortality of other significant life-threatening diseases (such as cancer). Secondary endpoints also include poor success in secondary prevention, which can be assessed through completed medication purchases and the achievement of secondary prevention goals.\n\nThis observational, prospective study includes collecting multimodal data from hospitals in Finland (TAUH), Israel (HYMC), Moldova (IMSP) and Romania (UMFCD). Each participating institution has followed a process structured by Tampere Heart Hospital (TAUH) for securing permissions in line with EU and national regulations.",[337,136,28],"Coronary Arterial Disease (CAD)",[339,340,206,341,342,343],"Coronary artery disease","Sudden cardiac arrest","post operative atrial fibrillation","genetics","risk factors","2026-03-02",{"date":346,"type":41},"2026-03-03",{"date":348,"type":41},"2025-01-05",{"date":239,"type":21},{"name":351,"class":80},"Tampere Heart Hospital",3,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":59,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":211,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":156},"100624900","dilated-cardiomyopathy---unknown-therapeutic-risk-reduction-by-contempary-medication-and-implantable-cardioverter-defibrillators-dutch-icd-100624900","NCT07415642","Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)","Using Cardiovascular Magnetic Resonance Identified Fibrosis to Assess Sudden Cardiac Death Risk in Patients With Non-ischemic Dilated Cardiomyopathy and the Unknown Therapeutic Risk Reduction of Contemporary Heart Failure Medication and Implantable Cardioverter-Defibrillators","DUTCH-ICD","Inclusion Criteria:\n\n* Non-ischemic cardiomyopathy\n* Left ventricular late gadolinium enhancement on MRI, but not hinge-point fibrosis\n* Left ventricular ejection fraction \\\u003C35% on any modality\n* Functional class NYHA I-III\n* At least 3 months optimal medical treatment for heart failure\n\nExclusion Criteria:\n\n* Indication for cardiac resynchronization therapy\n* Functional class NYHA IV\n* Typical ischemic scar tissue on CMR\n* Amyloidosis, sarcoidosis, hypertrophic cardiomyopathy, complex congenital heart disease\n* high-risk mutations causing DCM\n* Patient on waiting list for heart transplantation\n* Left ventricular assist device present\n* Severe valve disease\n* Secondary prevention indication for ICD\n* Untreated cardiac ischemia\n* High competing risk of death (\\>35% in 1 year according to HFmetascore)\n* Active chemotherapy for cancer\n* Severe renal failure with dialysis expected within 3 years",{"count":362,"type":21},720,[169],"Research questions: The value of primary prevention implantable cardioverter-defibrillator implantation (ICD) therapy in patients with non-ischemic cardiomyopathy (NICM) is under debate. Improved risk stratification is needed to select patients at highest risk.\n\nHypotheses: 1. In NICM patients with CMR detected myocardial fibrosis, ICD implantation reduces all-cause mortality compared to guideline-directed medical therapy (GDMT) only. 2. Myocardial fibrosis assessed by cardiac MRI (CMR) can be used to stratify patients according to risk for sudden cardiac death.\n\nStudy design: 1. Patients with myocardial fibrosis: Randomized controlled trial (RCT). 2. Patients without myocardial fibrosis: Prospective registry.\n\nStudy population: Patients with non-ischemic cardiomyopathy with LVEF \\\u003C35% after at least 3 months of guideline-directed medical therapy (GDMT).\n\nIntervention: ICD implantation. Main study parameters\u002Fendpoints: primary endpoint: all-cause mortality. Secondary endpoints include: patient clinical status, quality of life, sudden cardiac death, ventricular arrhythmias, ICD complications and ICD therapy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All ICDs that are implanted in the study are standard devices that are used in daily clinical practice. Patients who are randomized to ICD implantation will be subjected to the risk of perioperative and long-term complications but will be partly protected against death from ventricular arrhythmias. Patients randomized to no ICD implantation will not be protected against the residual risk of sudden cardiac death but are not subjected to complications from ICD implantation and possible subsequent complications. The only additional burden for patients is completing quality-of-life questionnaires, all hospital visits are for routine follow-up.",[28],[367,368,369,370],"implantable cardioverter defibrillator","non-ischemic dilated cardiomyopathy","magnetic resonance imaging","heart failure","2026-02-09",{"date":373,"type":41},"2026-02-17",{"date":375,"type":21},"2026-03-01",{"date":377,"type":21},"2032-12-31",{"name":379,"class":80},"University Medical Center Groningen",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":331,"enrollmentInfo":387,"targetDuration":4,"studyType":59,"phases":389,"briefSummary":390,"conditions":391,"keywords":395,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":49},"100621559","left-bundle-branch-pacing-in-patients-with-hypertrophic-cardiomyopathy-after-myectomy-100621559","NCT07372196","Left Bundle Branch Pacing in Patients With Hypertrophic Cardiomyopathy After Myectomy","LEFTpaceHCM","Inclusion criteria:\n\n* Men and women aged 18 years and older;\n* Patients with post-myectomy HCM who develop LBBB with a QRS complex greater than 130 ms and a high risk of SCD (HCM Risk-SCD ≥ 6%);\n* Signed informed consent to participate in the study;\n\nExclusion criteria:\n\n* Absence of QRS complex morphology consistent with LBBB in LBBB with a positive QRS complex less than 130 ms;\n* Presence of baseline complete RBBB;\n* Heart transplantation or implantation of an LVAD is planned within the next 6 months;\n* Patients with intermediate or low risk of SCD;\n* History of AMI less than three months prior to study inclusion;\n* Acute renal and hepatic failure;\n* Acute infectious diseases;\n* Presence of mental illness;\n* Presence of other illnesses for which life expectancy is less than one year;\n* Patient refusal to participate in the study at any stage;",{"count":388,"type":21},30,[169],"Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the occurrence of life-threatening rhythm disturbances and promote reverse remodeling of the LV.\n\nThe aim of the study is to evaluate the comparative efficacy and safety of implantation of a cardioverter-defibrillator with left bundle branch block pacing and a dual-chamber cardioverter-defibrillator in patients with HCM and complete left bundle branch block after myectomy at high risk of SCD.\n\nObjectives of the study:\n\n1. To analyze the safety of ICD implantation procedures with LBBB pacing in patients with HCM and LBBB after myectomy at high risk of SCD;\n2. To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy;\n3. To conduct a comparative analysis of QRS complex duration data based on ECG data before and after surgery, LV activation time, and pacing threshold based on postoperative programming data;\n4. To conduct a comparative analysis of the functional class of CHF, NT-proBNP, the presence\u002Fabsence of interventricular and intraventricular dyssynchrony, the degree of diastolic dysfunction, LVEF, and LV EDV based on echocardiography data before and 12 months after surgery;\n5. Conduct a comparative analysis of QRS complex duration data based on ECG data, LV activation time, pacing threshold, the presence of recorded episodes of AF, VT, VF, antitachycardia and shock therapy according to programming data at 3, 6, and 12 months after surgery;\n6. Assess quality of life before and 12 months after surgery using the KCCQ-12 questionnaire; 30 patients (15 patients in each group) will be randomly separated into 2 groups. All participants go through ICD programming at 3, 6, and 12 months after myectomy, assessment of left ventricular remodeling based on ECG and echocardiography, NT-proBNP, assessment of quality of life before surgery and 12 months after surgery.",[392,28,393,70,394],"HCM - Hypertrophic Cardiomyopathy","Left Bundle Branch Pacing","Heart Failure (HF)",[396,397,393,70,398,399],"sudden cardiac death","Hypertrophic Cardiomyopathy","Heart failure","myectomy","2026-01-20",{"date":402,"type":41},"2026-01-28",{"date":404,"type":41},"2025-11-14",{"date":406,"type":21},"2027-07-01",{"name":408,"class":409},"Meshalkin Research Institute of Pathology of Circulation","NETWORK",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":49},"100071316","imaging-techniques-for-identifying-factors-of-sudden-cardiac-death-risk-100071316","NCT00181233","Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk","Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death","Inclusion Criteria:\n\n* Left ventricular ejection fraction \\\u003Cor = 35%\n* Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)\n\nExclusion Criteria:\n\n* History of sudden death (secondary prevention)\n* Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)",{"count":418,"type":21},400,"Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately increasing in prevalence. Because it is difficult to predict those at highest risk, this study is designed to test the hypothesis that new imaging techniques (magnetic resonance imaging \\[MRI\\] and computed tomography \\[CT\\]) are useful for identifying factors which put people at high risk for sudden death.",[28],"2026-01-12",{"date":423,"type":41},"2026-01-14",{"date":425,"type":4},"2003-10",{"date":427,"type":21},"2029-07",{"name":429,"class":80},"Johns Hopkins University",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":59,"phases":439,"briefSummary":440,"conditions":441,"keywords":446,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":461},"100590211","phase-4-comparative-effectiveness-of-carvedilol-versus-metoprolol-succinate-in-heart-failure-patients-with-an-implantable-cardioverter-defibrillator-100590211","NCT06964464","Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator","CARVTOP-ICD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability\n* Current treatment with metoprolol succinate and willing to switch to carvedilol\n* LVEF \\\u003C50% during the past 12 months prior to consent\n\nExclusion Criteria:\n\n* Unwilling or unable to follow the protocol\n* Treatment with any other ßB than metoprolol succinate or no ßB treatment\n* Known prior intolerance or contraindication to carvedilol\n* Systolic blood pressure \\\u003C100 mmHg\n* Enrollment in another clinical trial\n* Inability or unwilling to consent",{"count":438,"type":21},2000,[61],"This prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection fraction (HFrEF) and an implantable cardioverter defibrillator (ICD). The study will enroll 2,000 participants across 100 U.S. sites and includes an 18-month feasibility phase with 100 participants from 15 sites. Eligible participants must be currently treated with metoprolol succinate and willing to switch to carvedilol, with randomization in a 1:1 ratio. Participants will be followed for up to 3 years, with regular assessments including ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys. The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular (CV) hospitalization, or CV death. Secondary endpoints include ICD shock burden, healthcare utilization, and patient-reported quality of life. The trial aims to provide high-quality comparative data to address clinical equipoise surrounding the two commonly used beta-blockers in HFrEF management.",[442,28,210,443,444,445],"Heart Failure With Reduced Ejection Fraction (HFrEF)","Implantable Cardioverter Defibrillator (ICD)","Beta-blocker Therapy","Cardiomyopathy",[447,370,70,367,448,449,450,451],"arrhythmia","ICD shock","carvedilol","metoprolol succinate","beta-blocker","2025-09-12",{"date":454,"type":41},"2025-09-18",{"date":456,"type":41},"2025-08-17",{"date":458,"type":21},"2031-07-01",{"name":460,"class":80},"University of Rochester",13,{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":59,"phases":472,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":156},"100575393","s-icd-implantation-us-based-pilot-study-100575393","NCT06771700","S-ICD Implantation: US Based Pilot Study","Feasibility of an Intra-operative and Non-fluoroscopic Subcutaneous ICD Positioning and Assessment of the PRAETORIAN Score During Implantation: a Pilot Study","SUSTAIN S-ICD","Inclusion Criteria:\n\n* consecutive patients presenting for S-ICD implantation at our institution\n\nExclusion Criteria:\n\n* patients unable to consent.\n* pregnancy",{"count":471,"type":21},20,[169],"This trial investigates two key aspects of the S-ICD implantation process. 1) For S-ICD implantation a pre-operative x-ray-based assessment of the anatomy and location of the heart is required. This study seeks to investigate the feasibility of US to potentially replace the need for x-ray 2) The PRAETORIAN score predicts defibrillation test success in subcutaneous ICD implantation but can only be calculated after the procedure. This pilot study aims to evaluate the feasibility of US determining the PRAETORIAN score intraoperatively. Lead-to-sternum distance and generator position measurments during the implantation procedure will be evaluated. Twenty consecutive patients scheduled for S-ICD implantation will be enrolled. The study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest X-ray on day one.",[28],[476,477],"S-ICD","Defibrillator","2025-07-03",{"date":480,"type":41},"2025-07-09",{"date":482,"type":41},"2025-03-01",{"date":484,"type":21},"2025-11-01",{"name":486,"class":80},"Universitätsklinikum Köln",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":496,"conditions":497,"keywords":505,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":511,"leadSponsor":513,"locationsCount":49},"100589414","mechanisms-and-prognosis-of-stroke-heart-syndrome-100589414","NCT06954103","Mechanisms And Prognosis of Stroke-Heart Syndrome","MAP-SHS","Inclusion Criteria:\n\n1. Patients admitted within 48 hours of onset, confirmed by CT\u002FMRI as having a stroke (including acute ischemic stroke and hemorrhagic stroke).\n2. Moderate-to-severe stroke with NIHSS ≥ 5.\n\nExclusion Criteria:\n\n1. Previous focal brain injury (such as stroke, brain surgery, traumatic brain injury, etc.).\n2. Brain dysfunction caused by other major neurological disorders than stroke (such as brain tumors, epilepsy, Parkinson's disease, etc.).\n3. Transient ischemic attack (TIA) and subarachnoid hemorrhage (SAH).\n4. History of cardiac diseases (such as coronary heart disease, heart failure, severe arrhythmias, congenital heart disease, cardiac surgery, valvular heart disease, or undiagnosed significant cardiac symptoms).\n5. Concomitant systemic diseases such as renal failure (eGFR \\\u003C 30), autoimmune disorders, severe infections, etc.\n6. History of dementia, depression, or other psychiatric disorders.\n7. Poor compliance and inability to cooperate with follow-up.",{"count":495,"type":21},658,"The incidence of stroke-heart syndrome following acute stroke, which encompasses both acute ischemic stroke and acute intracerebral hemorrhage, is notably high and is strongly associated with increased mortality and poor outcomes in stroke patients. However, the underlying mechanisms remain unclear, and there are currently no effective prevention or treatment strategies. This study aims to elucidate the neuro-humoral mechanisms of stroke-heart syndrome through multimodal imaging and multi-omics blood analysis. Additionally, it seeks to observe the progression of stroke-heart syndrome and its impact on functional outcomes, cognitive abilities, and emotional issues post-stroke. The research is expected to uncover novel blood biomarkers and brain network mechanisms associated with stroke-heart syndrome, providing potential targets and theoretical foundations for pharmacological treatments or physical interventions. Furthermore, it aims to establish a risk early-warning system for major cardiovascular complications post-stroke, enabling early identification, early intervention, and integrated brain-heart management to improve clinical outcomes for stroke patients.",[498,499,500,501,502,28,503,504],"Stroke","Myocardial Injury","Heart Failure","Acute Coronary Syndromes","Arrhythmia","Takotsubo Syndrome","Heart Rate Variability",[506],"Stroke-heart syndrome","2025-04-23",{"date":509,"type":41},"2025-05-01",{"date":482,"type":41},{"date":512,"type":21},"2028-04-01",{"name":514,"class":80},"Chensheng Pan",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":521,"enrollmentInfo":522,"targetDuration":4,"studyType":59,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":49},"100582017","myocardialbridge-bypass-graft-surgery-efficacy-verification-100582017","NCT06857838","Myocardialbridge Bypass Graft Surgery Efficacy Verification","Inclusion Criteria:\n\n* Patients with myocardialbridge requiring drug therapy or surgical intervention.\n\nExclusion Criteria:\n\n* patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason","80 Years",{"count":523,"type":21},500,[169],"Myocardial Bridge Bypass Graft surgery is introduced to relieve the unmedical symptoms of patients with long-segment or deep myocardial bridge, clinical outcomes will be collected to verify the effectiveness of the surgery.",[527,528,529,204,179,530,28,531,532,533],"Myocardial Bridge of Coronary Artery","Myocardial Bridge","Myocardial Bridging","Pectoris, Stable Angina","Bypass Graft Stenosis","Bypass Graft Occlusion","Bypass Graft Thrombosis","2025-02-26",{"date":536,"type":41},"2025-03-04",{"date":538,"type":41},"2020-01-01",{"date":540,"type":21},"2040-12-31",{"name":542,"class":80},"Xi'an International Medical Center Hospital",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":16,"minAge":551,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":554,"conditions":555,"keywords":570,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":352},"100578603","characterization-of-patients-with-cardiomyopathy-to-identify-critical-patients-candidates-for-cardiac-transplantation-100578603","NCT06813443","Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation","Clinical, Instrumental, and Molecular (Circulating and Tissue microRNAs) Characterization of Patients With Cardiomyopathy to Identify Critical Patients With Severe Organ Failure to be Candidates for Cardiac Transplantation","CMPMIRNA","Inclusion Criteria:\n\n* Patients diagnosed with CMP according to current international guidelines\n* Age ≥ 12 years at the time of diagnosis\n* Obtaining informed consent from the patient and the parent or legal guardian (in the case of patients aged \\\u003C 18 years)\n\nExclusion Criteria:\n\n* none","12 Years",{"count":553,"type":21},700,"The study aims to identify new diagnostic and prognostic markers for CMP that can help predict disease progression. In particular, the study will focus on microRNAs (miRNAs) and spatial transcriptomics, which are emerging techniques that may provide insights into the underlying disease mechanisms. By understanding these markers, the investigators hope to improve the way the investigators diagnose and manage CMP, particularly in terms of predicting progression to heart failure or heart transplantation.\n\nThe study will evaluate patients with hypertrophic cardiomyopathy (e.g., sarcomeric forms, Anderson-Fabry disease, AL, and TTR cardiac amyloidosis), dilated cardiomyopathy and arrhythmogenic cardiomyopathy. These patients will undergo clinical evaluations, including ECG, echocardiograms, CMR, biopsy analysis, and genetic testing, as well as molecular studies such as transcriptomics and miRNA analysis. This comprehensive approach aims to identify potential new biomarkers for diagnosing and predicting the disease course.",[133,556,557,558,559,560,561,562,563,28,564,565,566,567,284,568,569],"Amyloidosis Cardiac","Fabry Disease","Arrhythmogenic Cardiomyopathy","Hypertrophic Cardiomyopathy (HCM)","Laminopathies","Dystrophia Myotonica","Mitochondrial Cardiomyopathy","Dilated Cardiomyopathy","Heart Transplantation","Glycogen Storage Disease","Infiltrative Cardiomyopathy","Cardiac Magnetic Resonance Imaging","Micro RNA","Echocardiogram",[571,572,573,574,575,396,576,370,577],"cardiomyopathy","cardiac amyloidosis","Fabry disease","hypertrophic cardiomyopathy","dilated cardiomyopathy","arrhythmogenic cardiomyopathy","heart transplantation","2025-02-03",{"date":580,"type":41},"2025-02-07",{"date":582,"type":41},"2023-02-13",{"date":584,"type":21},"2027-12-14",{"name":586,"class":80},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":594,"targetDuration":596,"studyType":22,"phases":4,"briefSummary":597,"conditions":598,"keywords":601,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":49},"100577915","tampere-coronary-artery-disease-and-sudden-cardiac-arrest-study-100577915","NCT06804499","Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study","CADSCA","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. A patient who lives in the area of 'Wellbeing Services County of Pirkanmaa' and seeks treatment for coronary artery disease (CAD).\n3. CAD is diagnosed with invasive coronary angiogram or computed tomography angiogram (CTA) which is evaluated by cardiologists based on current guidelines for stenosis level evaluation and fractional flow reserve (FFR) results.\n4. An invasive coronary angiogram or CTA is done within three (3) months.\n5. Good or moderate everyday functional ability\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C1 months.\n2. A significant valvular heart disease treated previously (endovascular or surgical) or requires treatment (endovascular or surgical) in the next three (3) months.\n3. Previously implanted cardioverter-defibrillators (ICD) or will be implanted in the next three (3) months.\n4. An active malignancy (ongoing treatment for a solid tumour, metastatic solid tumour, fast progressing haematological malignancy, or equal malignant disease).\n5. A significant neurodegenerative disease (dementia, Mini-Mental State Examination (MMSE) \\\u003C23 or equivalenneurodegenerative disease affecting everyday functional ability, like ALS, myositis, prograded MS-disease or Parkinson's disease).\n6. Intellectual disability or a significant disability affecting cognitive functions\n7. Do-not-resuscitate (DNR) treatment decision\n\nSubgroup with blood samples:\n\nBlood samples are withdrawn from all study subjects under 76 years of age. Additionally, PaxGene samples are withdrawn from i) all study subjects under 65 years of age and ii) subjects between 65-76 years, if they have detected QRS-time\\>110ms in the latest ECG.",{"count":595,"type":21},4000,"15 Years","The goal of this observational study is to recognize clinical and genetic risk factors for sudden cardiac arrest (SCA) and death (SCD) in patients with coronary artery disease (CAD).\n\nThe main questions it aims to answer are:\n\nAre we able to recognize clinical or treatment-related risk factors for SCA or SCD? Can we identify new genetic risk factors for SCA or SCD in patients under 75 years?\n\nParticipants diagnosed with CAD answer a short survey about their medical history and socioeconomic status. A standard ECG addition to a five (5) minute ECG recording is taken from all the study subjects. In addition to a few short physiological tests (e.g. blood pressure, height, weight, grip strength), a blood sample is withdrawn from a selected group of study subjects.\n\nMedical healthcare records are used to follow all study subjects, and no follow-up visits are required.",[136,28,599,337,600],"Sudden Cardiac Death Due to Cardiac Arrhythmia","Acute Coronary Event",[396,602,603,604],"sudden cardiac arrest","coronary artery disease","acute coronary syndrome","2025-01-27",{"date":578,"type":41},{"date":608,"type":41},"2025-01-13",{"date":610,"type":21},"2042-12-31",{"name":351,"class":80},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":16,"minAge":551,"maxAge":620,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":623,"conditions":624,"keywords":625,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":81},"100565437","sudden-cardiac-arrest-related-to-sport-in-young-and-value-of-the-genetic-assessment-a-french-prospective-register-100565437","NCT06642168","Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register","Registre Prospectif Français Des Morts Subites Chez Des Sportifs Jeunes","RESOUDRE","Inclusion Criteria:\n\n* Victims of SCA:\n\n  * Aged between 12 and 35 years\n  * No known cardiovascular pathology\n  * Experienced a sudden and non-traumatic SCA during or within one hour of participating in sports activities (leisure, training, or competition)\n  * For resuscitated victims (SCA group): A person or legal representative who does not oppose participation in the research after being informed about the study (including individuals, organs, or authorities responsible for assisting or representing them if they are unable to express their wishes).\n  * For non-resuscitated victims (SCD group): A person who has not formally objected to the reuse of their medical data during their lifetime.\n* First-Degree Relatives:\n\n  * A person or legal representative who does not oppose participation in the research after being informed about the study (including individuals, bodies, or authorities responsible for assisting or representing them if they are unable to express their wishes).\n\nNon-Inclusion Criteria:\n\n* For resuscitated SCA cases, individuals weighing less than 20 kg\n* Victims or legal representatives who are subject to legal protection or deprived of their liberty","35 Years",{"count":622,"type":21},80,"The increased risk of sudden cardiac arrest (SCA) or sudden cardiac death (SCD) related to vigorous physical activity is well-documented. Currently, for young victims (under 35 years) of SCA\u002FSCD, no etiology is found in 40 to 50% of cases after a standard medical assessment, leading to two important consequences. For the victim's family, it is difficult to understand and accept this tragic event, and the risk of it occurring in another family member is a source of concern. Medically, the absence of a known cause limits the ability to effectively prevent such events.\n\nThe RESOUDRE study will be a national, prospective, observational registry of young victims (12-35 years) of sports-related SCA\u002FSCD. All cases will undergo the recommended etiological assessment, including autopsy for SCA cases, along with whole exome genetic analysis and toxicological testing. In the event a genetic pathology is identified, a genetic evaluation will be offered to other family members, and appropriate medical care will be provided if necessary. The results of this study could significantly reduce the number of unexplained sport-related SCA\u002FSCD cases and aid in preventing these incidents among affected families.",[136,28],[626,627,628,629,630,631,632,633,634],"Sport related sudden cardiac arrest","Sport related sudden cardiac death","Young athlete","Etiological Diagnosis","Autopsy","Genetic","Toxicology","Hereditary Cardiac disease","Prevention","2025-01-07",{"date":637,"type":41},"2025-01-08",{"date":639,"type":41},"2024-10-11",{"date":641,"type":21},"2028-01-11",{"name":643,"class":80},"Rennes University Hospital",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":652,"targetDuration":654,"studyType":22,"phases":4,"briefSummary":655,"conditions":656,"keywords":658,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":352},"100540000","multicenter-evaluation-of-patients-using-latitude-monitoring-system-100540000","NCT06311149","Multicenter Evaluation of Patients Using LATITUDE Monitoring System","Multicenter Evaluation of Patients Using LATITUDE Monitoring System: Multitude Study","Multitude","Inclusion Criteria:\n\n* Subject is willing and capable of providing informed consent to collect\u002Fstore\u002Fprocess personal health information by the sponsor or such consent is provided by a legally designated representative, if required by local law or regulation.\n* Subject is:\n\n  1. prospectively scheduled for receiving a device monitored through the LATITUDE monitoring system\n  2. retrospectively enrolled after having received a device monitored through the LATITUDE monitoring system\n\nExclusion Criteria:\n\n* Subject foreseen not to be followed at the enrolling center for at least 1 year after having received the device.\n* Subject is receiving a device that is not approved for commercial use at the time of procedure.",{"count":653,"type":21},20000,"10 Years","The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.\n\nThe registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.\n\nThe Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle.",[135,657,500,28],"Arrhythmias, Cardiac",[659,660,661,662,663,664,665,666],"Cardiac implantable electrical device","Implantable cardioverter defibrillator","Pacemaker","Cardiac resynchronization therapy","Subcutaneous defibrillator","Implantable cardiac monitor","Remote monitoring","Latitude monitoring system","2024-08-08",{"date":669,"type":41},"2024-08-12",{"date":671,"type":41},"2023-12-01",{"date":673,"type":21},"2043-12-31",{"name":675,"class":80},"University Hospital of Ferrara",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":684,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":686,"conditions":687,"keywords":688,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":49},"100469226","the-international-subcutaneous-implantable-cardioverter-defibrillator-registry-isusi-100469226","NCT05390047","The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)","The International Subcutaneous Implantable Cardioverter Defibrillator Registry (iSuSi)","iSuSI","Inclusion Criteria:\n\n* Implantation of an S-ICD, regardless of the technique\n* At least 1 month of follow up\n* At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center (e.g. in person visit or remote follow up)\n\nExclusion Criteria:\n\n\\- none","99 Years",{"count":595,"type":21},"The entirely subcutaneous implantable defibrillator (S-ICD) (Emblem, Boston Scientific, Marlborough, MA, USA) was introduced as a new therapeutic alternative to the conventional transvenous ICD in 2009 and implantations are rapidly expanding since then.1 Implantation of the S-ICD seems to reduce implant-related perioperative complications such as pneumothorax, hematoma and cardiac tamponade.\n\nThe aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting.",[28],[689],"subcutaneous implantable cardioverter defibrillator","2024-06-28",{"date":692,"type":41},"2024-07-01",{"date":694,"type":41},"2022-07-01",{"date":696,"type":21},"2025-09-30",{"name":698,"class":80},"University of Luebeck",{"id":700,"slug":701,"hasResults":12,"nctId":702,"briefTitle":703,"officialTitle":703,"acronym":4,"eligibilityCriteria":704,"healthyVolunteers":127,"sex":16,"minAge":705,"maxAge":706,"enrollmentInfo":707,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":709,"conditions":710,"keywords":711,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":713,"lastUpdatePostDateStruct":714,"startDateStruct":716,"completionDateStruct":718,"leadSponsor":719,"locationsCount":49},"100549901","pre-warning-risk-scoring-system-for-sudden-cardiac-death-100549901","NCT06440083","Pre-warning Risk Scoring System for Sudden Cardiac Death","Inclusion Criteria:\n\nThe subjects with the following diagnosis of one or more cardiovascular diseases:\n\n1. Coronary heart disease If there is a history of coronary heart disease or a new diagnosis of coronary heart disease, or with a report of coronary angiography that indicates at least one vascular stenosis\\>50%. Diagnosis includes chronic coronary syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina, ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction).\n2. Heart failure Individuals with a history of heart failure or newly diagnosed heart failure, including heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction (LVEF) ≤40%)、intermediate heart failure (HFmrEF, LVEF 41%-49%，with evidence of spontaneous or excitable increase in left ventricular filling pressure), and ejection fraction preserving heart failure (HFpEF, LVEF≥50%, there is evidence of spontaneous or excitable increase in left ventricular filling pressure).\n3. Genetically related cardiomyopathy or arrhythmia Cardiomyopathy includes hypertrophic cardiomyopathy (DCM), dilated cardiomyopathy (HCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), inflammatory cardiomyopathy (myocarditis, sarcoidosis, Chagas disease). Hereditary arrhythmias include long QT syndrome, short QT syndrome, Brugada syndrome, idiopathic ventricular fibrillation, catecholamine sensitive polymorphic ventricular tachycardia (CPVT), early repolarization syndrome, etc.\n\n2\\) Sign an informed consent form.\n\nExclusion Criteria:\n\n1. Age\\\u003C16 years old;\n2. Refusal to the follow-up visits;\n3. Individuals with severe mental disorders who are unable to express their wishes;\n4. Other obvious physical diseases and abnormal laboratory test results;\n5. Patients deemed unsuitable for participation in this study by the supervising physician.","16 Years","90 Years",{"count":708,"type":21},100000,"The goal of this observational study is to identify potential indicators for pre-warning of sudden cardiac death (SCD), including clinical biochemistry markers, electrocardiogram, echocardiography, MRI and CT imaging values, genetic markers and so on, and further construct a series of multi-parameter assessments of SCD early screening.",[28],[28,712],"Cohort study","2024-06-03",{"date":715,"type":41},"2024-06-05",{"date":717,"type":41},"2023-03-02",{"date":239,"type":21},{"name":720,"class":80},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":722,"slug":723,"hasResults":12,"nctId":724,"briefTitle":725,"officialTitle":725,"acronym":726,"eligibilityCriteria":727,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":728,"enrollmentInfo":729,"targetDuration":4,"studyType":59,"phases":731,"briefSummary":732,"conditions":733,"keywords":734,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":745},"100330903","programmed-ventricular-stimulation-to-risk-stratify-for-early-cardioverter-defibrillator-icd-implantation-to-prevent-tachyarrhythmias-following-acute-myocardial-infarction-protect-icd-100330903","NCT03588286","Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)","PROTECT-ICD","Inclusion Criteria:\n\n* 2-40 days (inclusive) following a myocardial infarct\n* Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired)\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>85;\n2. Pregnancy;\n3. Nursing home resident dependent on one or more activities of daily living;\n4. Significant non-cardiac co-morbidity with high likelihood of death within 1 year (this would include any metastatic malignancy, or other terminal disease);\n5. Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up;\n6. Intravenous drug abuse (ongoing);\n7. Unresolved infection associated with risk for hematogenous seeding;\n8. Pre-existing implantable cardioverter-defibrillator (ICD);\n9. Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded));\n10. On the heart transplant list;\n11. Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications);\\*\\*\n12. Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)\\*\\* \\*\\*NOTE: patients who meet exclusion based on (11) or (12) can be reviewed again in 2-3 days and if symptoms have resolved or treatment performed can be re-considered for inclusion.","85 Years",{"count":730,"type":21},1058,[169],"The PROTECT-ICD trial is a physician-led, multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have poor cardiac function following a myocardial infarct (MI). The trial aims to assess the role of electrophysiology study (EPS) in guiding implantable cardioverter-defibrillator (ICD) implantation, in patients early following MI (first 40 days). The secondary aim is to assess the utility of cardiac MRI (CMR) in analysing cardiac function and viability as well as predicting inducible and spontaneous ventricular tachyarrhythmia when performed early post MI.\n\nFollowing a MI patients are at high risk of sudden cardiac death (SCD). The risk is highest in the first 40 days; however, current guidelines exclude patients from receiving an ICD during this time. This limitation is based largely on a single study, The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), which failed to demonstrate a benefit of early ICD implantation. However, this study was underpowered and used non-invasive tests to identify patients at high risk. EPS identifies patients with the substrate for re-entrant tachyarrhythmia, and has been found in multiple studies to predict patients at risk of SCD. Contrast-enhanced CMR is a non-invasive test without radiation exposure which can be used to assess left ventricular function. In addition, it provides information on myocardial viability, scar size and tissue heterogeneity. It has an emerging role as a predictor of mortality and spontaneous ventricular arrhythmia in patients with a previous MI.\n\nA total of 1,058 patients who are at high risk of SCD based on poor cardiac function (left ventricular ejection fraction (LVEF) ≤40%) following a ST-elevation or non-STE myocardial infarct will be enrolled in the trial. Patients will be randomised 1:1 to either the intervention or control arm.\n\nIn the intervention arm all patients undergo early EPS. Patients with a positive study (inducible ventricular tachycardia cycle length ≥200ms) receive an ICD, while patients with a negative study (inducible ventricular fibrillation or no inducible VT) are discharged without an ICD, regardless of the LVEF.\n\nIn the control arm patients are treated according to standard local practice. This involves early discharge and repeat assessment of cardiac function after 40 days or after 90 days following revascularisation (PCI or CABG). ICD implantation after 40 days according to current guidelines (LVEF≤30%, or ≤35% with New York Heart Association (NYHA) class II\u002FIII symptoms) could be considered, if part of local standard practice, however the ICD is not funded by the trial.\n\nA proportion of trial patients from both the intervention and control arms at \\>48 hours following MI will undergo CMR to enable correlation with (1) inducible VT at EPS and (2) SCD and non-fatal arrhythmia on follow up. It will be used to simultaneously assess left ventricular function, ventricular strain, myocardial infarction size, and peri-infarction injury. The size of the infarct core, infarct gray zone (as a measure of tissue heterogeneity) and total infarct size will be quantified for each patient.\n\nAll patients will be followed for 2 years with a combined primary endpoint of non-fatal arrhythmia and SCD. Non-fatal arrhythmia includes resuscitated cardiac arrest, sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) in participants without an ICD. Secondary endpoints will include all-cause mortality, non-sudden cardiovascular death, non-fatal repeat MI, heart failure and inappropriate ICD denial. Secondary endpoints for CMR correlation will include (1) the presence or absence of inducible VT at EP study, and (2) combined endpoint of appropriate ICD activation or SCD at follow up.\n\nIt is anticipated that the intervention arm will reduce the primary endpoint as a result of prevention of a) early sudden cardiac deaths\u002Fcardiac arrest, and b) sudden cardiac death\u002Fcardiac arrest in patients with a LVEF of 31-40%. It is expected that the 2-year primary endpoint rate will be reduced from 6.7% in the control arm to 2.8% in the intervention arm with a relative risk reduction (RRR) of 68%. A two-group chi-squared test with a 0.05 two-sided significance level will have 80% power to detect the difference between a Group 1 proportion of 0.028 experiencing the primary endpoint and a Group 2 proportion of 0.067 experiencing the primary endpoint when the sample size in each group is 470. Assuming 1% crossover and 10% loss to follow up the required sample size is 1,058 (n=529 patients per arm). To test the hypothesis that tissue heterogeneity at CMR predicts both inducible and spontaneous ventricular tachyarrhythmias will require a sample size of 400 patients to undergo CMR.\n\nIt is anticipated that the use of EPS will select a group of patients who will benefit from an ICD soon after a MI. This has the potential to change clinical guidelines and save a large number of lives.",[28],[735],"Myocardial Infarction (MI), Sudden Cardiac Death (SCD), Electrophysiological Study (EPS), Ventricular Tachycardia (VT)","2024-05-06",{"date":738,"type":41},"2024-05-07",{"date":740,"type":41},"2014-02-27",{"date":742,"type":21},"2029-12-06",{"name":744,"class":80},"Western Sydney Local Health District",52]