[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Institute of Cardiology, Warsaw, Poland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":259},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,78,105,128,158,185,209,236],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627565","cardionetpol-national-registry-of-carcinoid-heart-disease-100627565",false,"NCT07450287","CardioNETPOL National Registry of Carcinoid Heart Disease","Carcinoid Heart Disease National Registry of Poland","CardioNETPOL","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed diagnosis of a neuroendocrine tumor consistent with carcinoid heart disease.\n* Echocardiographic evidence of at least moderate valvular disease associated with endocardial fibrosis.\n* Elevated NT-proBNP levels (\\>260 ng\u002FL) consistent with cardiac dysfunction.\n* Availability of relevant clinical, echocardiographic, and laboratory data.\n* For patients who underwent cardiac surgery, histopathological confirmation of carcinoid-related cardiac tissue (if available).\n* Ability to provide informed consent for participation in the registry (or waiver as per local ethics approval for retrospective data).\n\nExclusion Criteria:\n\n* Patients with insufficient clinical or imaging data to confirm carcinoid heart disease.\n* Presence of other primary cardiac conditions causing significant valvular disease unrelated to carcinoid syndrome (e.g., rheumatic heart disease, congenital valve disease)\n* Active participation in interventional clinical trials that would conflict with registry data collection\n* Patients younger than 18 years","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","Carcinoid tumors are neuroendocrine tumors (NETs), most commonly originating from the gastrointestinal tract, that may secrete bioactive substances such as serotonin. Persistent exposure to these mediators can lead to carcinoid syndrome and, in up to 50% of patients, carcinoid heart disease (CHD). CHD is characterized by fibrotic degeneration of cardiac valves, predominantly right-sided, resulting in progressive valvular dysfunction and a significant increase in mortality.\n\nThe mechanisms underlying selective cardiac involvement and predictors of disease progression remain incompletely understood. In addition, optimal timing and selection of surgical versus transcatheter valve interventions, particularly in high-risk patients, require further clarification.\n\nThis multicenter, retrospective observational registry aims to identify and characterize patients with carcinoid heart disease and at least moderate valvular involvement. CHD is defined by confirmed neuroendocrine tumor, echocardiographic evidence of ≥ moderate valvular disease with features of fibrosis, elevated NT-proBNP (\\>260 ng\u002FL), and histopathological confirmation when available.\n\nApproximately 100-120 consecutive patients will be enrolled over 12 months. Standardized data collection will include detailed echocardiographic assessment, demographic and clinical characteristics, cardiovascular risk factors, comorbidities, tumor features, oncological treatment history, and cardiac management strategies.\n\nThe primary objective is to describe the clinical profile and management of patients with CHD in a real-world multicenter setting. Secondary objectives include identifying factors associated with advanced valvular dysfunction and evaluating eligibility and outcomes of transcatheter valve therapies. The registry is expected to improve risk stratification and support clinical decision-making in carcinoid heart disease.",[25,26,27,28],"Carcinoid Heart Disease","Neuroendocrine Tumors","Carcinoid Syndrome","Valvular Heart Disease Patients",[25,30,27,31,32,33,34,35],"Neuroendocrine Tumor","Valvular Heart Disease","Transcatheter Tricuspid Valve Intervention","Observational Study","Multicenter Registry","Right-Sided Heart Failure","NOT_YET_RECRUITING","2026-02-27",{"date":39,"type":40},"2026-03-04","ACTUAL",{"date":42,"type":21},"2026-06-01",{"date":44,"type":21},"2027-06-01",{"name":46,"class":47},"National Institute of Cardiology, Warsaw, Poland","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":22,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100618361","polish-registry-of-percutaneous-coronary-intervention-for-chronic-total-occlusions-100618361","NCT07330622","Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions","Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions (POL-CTO Registry)","POL-CTO","Inclusion Criteria:\n\n* Patients undergoing CTO PCI based on clinical grounds\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patient's refusal to participate in the registry",{"count":58,"type":21},1000,"1 Year","The goal of this observational study is to evaluate the safety, efficacy, and clinical outcomes of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients treated in contemporary clinical practice in Poland.\n\nThe main questions it aims to answer are:\n\n* What are the rates of procedural success and periprocedural complications of CTO PCI in routine clinical practice?\n* How do CTO PCI strategies and techniques, intravascular imaging, different treatment strategies, and mechanical circulatory support affect clinical outcomes?\n* How do clinical outcomes differ among different patient subgroups?\n* Can artificial intelligence-based analysis predict clinical and quality-of-life outcomes after CTO PCI?\n\nPatients undergoing CTO PCI as part of their standard medical care will be prospectively enrolled in a national, multicenter registry, with clinical, procedural, and follow-up data collected to evaluate real-world outcomes.",[62,63],"Coronary Occlusion","Percutaneous Coronary Intervention",[65,66,67],"coronary artery disease","percutaneous coronary intervention","coronary chronic total occlusion","RECRUITING","2025-12-29",{"date":71,"type":40},"2026-01-09",{"date":73,"type":40},"2025-05-21",{"date":75,"type":21},"2026-06",{"name":46,"class":47},21,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100583623","antegrade-dissection-and-re-entry-versus-retrograde-strategy-in-cto-pci-100583623","NCT06878729","Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI","Antegrade Dissection and Re-entry Versus Retrograde Strategy in Chronic Total Occlusion Percutaneous Coronary Intervention","ADRENALINE","Inclusion Criteria:\n\n* clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and\u002For documented ischemia or viability)\n* at least difficult native CTO lesion with J-CTO difficulty score ≥2 points on invasive angiography\n* angiographic suitability for both ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators\n* informed consent for participation in the study\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* acute myocardial infarction\n* cardiogenic shock\n* severe valvular disease\n* estimated life expectancy \\\u003C1 year\n* contraindication to PCI\n* contrast allergy\n* positive pregnancy test or breast-feeding\n* native CTO lesion with easy or intermediate difficulty score on invasive angiography (J-CTO score \\\u003C2 points)\n* lack of angiographic equipoise between the ADR and the retrograde strategy as assessed by 2 independent hybrid CTO PCI operators",{"count":87,"type":21},74,"INTERVENTIONAL",[90],"NA","The ADRENALINE trial has been designed as a multi-center, prospective randomized study to compare the procedural and periprocedural outcomes of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using antegrade dissection and re-entry (ADR) versus retrograde strategy. Beyond the patient-oriented outcomes, the influence of the studied CTO PCI strategies on the stress levels among interventional cardiologists will be explored.\n\nThe main questions it aims to answer are as follows:\n\n* What is the difference between ADR versus retrograde strategy with regard to total procedure time, the rates of successful guidewire crossing and periprocedural complications as well as stress levels experienced by interventional cardiologists?\n* Is retrograde approach associated with higher rates of myocardial injury\u002Finfarction based on cardiac troponin\u002Fcardiac magnetic resonance (CMR) as compared with ADR?\n\nParticipants will undergo pre- and postprocedural laboratory testing (cardiac troponin, CK-MB), CMR for late gadolinium enhancement and health status assessment. Subjects undergoing successful CTO PCI using antegrade wiring strategy will be included in the observational arm.",[93,62,63],"Coronary Artery Disease",[65,66,67,95,96],"antegrade dissection and re-entry","retrograde strategy",{"date":98,"type":40},"2026-01-02",{"date":100,"type":40},"2025-07-28",{"date":102,"type":21},"2028-09-30",{"name":46,"class":47},3,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":88,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100537250","drug-coated-balloon-in-native-chronic-total-occlusion-percutaneous-coronary-intervention-100537250","NCT06275386","Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention","Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)","IMAGINATION","Inclusion Criteria:\n\n* clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and\u002For documented ischemia or viability)\n* native CTO lesion as defined by invasive coronary angiography\n* informed consent for participation in the study\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* myocardial infarction\n* cardiogenic shock\n* severe valvular disease\n* estimated life expectancy \\\u003C1 year\n* contraindication to PCI\n* positive pregnancy test or breast-feeding\n* in-stent CTO\n* CTO recanalization using antegrade or retrograde dissection and re-entry techniques",{"count":114,"type":21},30,[90],"The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.",[93,118],"Total Occlusion of Coronary Artery",[120,66,121],"chronic total occlusion","drug-coated balloon",{"date":98,"type":40},{"date":124,"type":40},"2024-03-24",{"date":126,"type":21},"2026-05",{"name":46,"class":47},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":88,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":48},"100612514","phase-4-anti-atherosclerotic-efficacy-of-selected-antidiabetic-drugs-in-patients-with-coronary-artery-disease-and-pre-diabetes-100612514","NCT07254572","Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes","A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes","CASCADES","Inclusion Criteria:\n\n* Age 18 - 80\n* Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of \\>2.5 mm or status after percutaneous coronary revascularization procedure found on coronary CT scan)\n* Coronary CT scan performed \\\u003C3 months after inclusion in the study, at least of good quality\n* Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening\u002Frandomization appointment or within 30 days prior to the screening\u002Frandomization appointment) or documented, positive result of an oral glucose load test (fasting blood glucose 100-125 mg% and 140-199 mg% 2h after a 75 g oral glucose load) performed up to 30 days before the screening\u002Frandomization appointment\n* Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks\n* Willing and able to give informed consent to participate in the study\n* Willing and able, according to the researcher, to comply with all the requirements of the study\n\nExclusion Criteria:\n\n* Severe valvular defect\n* Clinical condition requiring surgical treatment of coronary artery disease\n* Status after coronary artery bypass surgery\n* Diagnosed diabetes or Hba1c\\>=6.5% at screening\u002Frandomization appointment\n* Other severe medical conditions requiring scheduled hospital treatment at the time of the study\n* Severe musculoskeletal conditions requiring specific rehabilitation recommendations\n* Diagnosed heart failure\n* Presence of an artificial valve, cardiac pacing system or other implantable device (such as a cardioverter defibrillator)\n* Severe arrhythmia\u002Funexplained loss of consciousness\n* Other contraindications to physical activity\n* No consent to participate in the study\n* Use of glucose-lowering drugs other than metformin\n* Use of weight-loss drugs\n* Condition after bariatric surgery\n* Diagnosed liver disease or ALT, AST above three times the upper limit of normal at screening appointment\n* Uncompensated hyperthyroidism\n* Pancreatic cancer\n* Medullary thyroid cancer\n* History of anaphylactic shock after iodine contrast administration\n* Chronic kidney disease (eGFR \\\u003C45 ml\u002Fmin\u002F1.73 m2)\n* History of pancreatitis or active pancreatitis\n* Body mass index (BMI) \\>40 kg\u002Fm2\n* Pregnancy\u002Flactation\n* Participation in another clinical trial\n* Other known contraindications to treatment with metformin, dapagliflozin or semaglutide","80 Years",{"count":138,"type":21},300,[140],"PHASE4","The purpose of the study is to compare the anti-atherosclerotic efficacy of oral treatment with a GLP-1 analogue (semaglutide) or an SGLT-2 (so-called \"flozin\") inhibitor (dapagliflozin) versus routine treatment (metformin) in patients with pre-diabetes and diagnosed coronary artery disease at 24 months.\n\nThe diagnosis of coronary artery disease will be defined as the presence of coronary atherosclerosis confirmed by coronary artery computed tomography (coronary CT).\n\nThe study will evaluate the effect of treatment with flozin vs. semaglutide compared to treatment with metformin on the progression\u002Fregression of coronary atherosclerosis, change in plaque character, and control of cardiovascular risk factors.",[93,143],"PreDiabetes",[93,145,146,147,148,149],"Prediabetes","Coronary Plaque","Metformin","SGLT-2","GLP-1","2025-11-25",{"date":152,"type":40},"2025-11-28",{"date":154,"type":40},"2025-07-10",{"date":156,"type":21},"2029-08-01",{"name":46,"class":47},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":48},"100604028","ai-assessment-of-low-gradient-aortic-stenosis-severity-based-on-echocardiography-100604028","NCT07144189","AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography","Artificial Intelligence-Based Assessment of Low-Gradient Aortic Stenosis Severity Using Echocardiographic Images","ASAI-POL","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical suspicion of significant low-gradient aortic stenosis\n* Echocardiographic examination performed for clinical indications\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Previous aortic valve intervention (surgical or transcatheter)\n* Inadequate image quality precluding echocardiographic analysis\n* Concomitant severe valvular disease (severe mitral stenosis or mitral\u002Faortic regurgitation) that could confound assessment\n* Patients unwilling or unable to provide informed consent",{"count":138,"type":21},"The purpose of this study is to evaluate the effectiveness of an artificial intelligence (AI) model developed by the investigators for identifying severe low-gradient aortic valve stenosis. Accurate assessment of stenosis severity is crucial for proper qualification for surgical treatment. It is expected that the use of AI will improve diagnostic accuracy and thereby support better clinical outcomes.\n\nPatients with suspected significant low-gradient aortic stenosis will be enrolled. The study is observational and involves no additional risk for participants. Standard imaging studies performed for clinical indications will be additionally analyzed by the AI model, which will classify aortic stenosis as severe or moderate. The model's results will not influence the clinical management of participants but will be compared with physicians' assessments to validate its diagnostic performance.\n\nThe study will be conducted in 2025-2026. The findings will provide insights into the usefulness of AI in the diagnosis of severe aortic stenosis and may contribute to the development of advanced clinical decision-support tools.",[169,170],"Low-gradient Aortic Stenosis","Aortic Stenosis",[172,173,174,175,176],"low-gradient aortic stenosis","Echocardiography","Artificial intelligence","Cardiac imaging","Machine learning","2025-11-24",{"date":179,"type":40},"2025-12-02",{"date":181,"type":40},"2025-08-20",{"date":183,"type":21},"2026-08-20",{"name":46,"class":47},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":88,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":48},"100490028","effects-of-switching-from-cigarettes-to-tobacco-heating-system-on-coronary-atherosclerosis-progression-100490028","NCT05660798","Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression","Effects of Switching From Cigarettes to Tobacco Heating System on Coronary Atherosclerosis Progression in Patients With Stable Coronary Artery Disease","SWITCH","Inclusion Criteria:\n\n1. Adults aged \\>18 years and \\\u003C75 years\n2. Subjects with stable chronic coronary syndrome defined as the presence of at least one coronary artery stenosis \\>=20% due to coronary plaque visible on coronary computed tomography angiography (CCTA), in an artery with a reference diameter \\> 2.0mm\n3. History of smoking pack-years ≥10 (Pack-years will be calculated by taking the average number of cigarettes smoked per day divided by 20 and multiplied by the number of years smoked), based on self-reporting\n4. Current smokers with a minimum of self-reported current smoking pattern of \\>10 cigarettes\u002Fday during the last 6 months prior to screening, smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng\u002FmL)\n5. Patients that have been advised to quit smoking and informed of a smoking risk and cessation programs (per local SOC) and who are still not willing to set a quit date within the next 30 days at screening\n6. Stable treatment for coronary atherosclerosis according to the guidelines\n7. Have understood the study and have signed informed consent\n\nExclusion Criteria:\n\n1. Any acute cardiovascular event (i.e. ACS, MI, Stroke, TIA, Limb ischemia), unstable angina or revascularization within 30 days prior to screening\n2. Planned coronary intervention (PCI, CABG) at screening\n3. Previous CABG\n4. Preexisting heart failure with reduced ejection fraction (EF \\\u003C50%)\n5. Severe uncontrolled hypertension (at the discretion of investigator)\n6. Diabetes\n7. Subjects with documented genetic familial hypercholesterolemia\n8. Subjects have known serious infection or chronic inflammatory systemic disease (e.g. rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)\n9. Subjects have a known non-cardiovascular disease that is associated with poor prognosis (e.g. metastatic cancer)\n10. Patient with currently active cancer or history of cancer within the last 5 years\n11. Subjects have hypersensitivity or any other warnings listed in the local labeling for THS\n12. Subjects have hypersensitivity to imaging iodine contrast agents\n13. GFR\\\u003C45 ml\u002Fmin\u002F1,73 m2\n14. Subjects who could not participate for any reason other than medical (e.g., psychological and\u002For social reason) per Investigator's judgment\n15. Subjects have any other clinical condition that would jeopardize the subject's safety while participating in this study, per Investigator's judgment\n16. Female subject is pregnant or breast-feeding, or planning to become pregnant during the study\n17. Subjects have previously participated in this study, or in an interventional study (drug or medical device) within 30 days of screening (participation in observational studies\u002Fregistries allowed)\n18. Subjects have a close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g. employee or student of the investigational site)\n19. Subjects are current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)","75 Years",{"count":195,"type":21},180,[90],"Objective:\n\nTo evaluate the impact of heated versus combustion tobacco products on progression of atherosclerosis in patients with CAD unable(unwilling) to quit smoking.\n\nRationale:\n\nDespite the efforts to curb smoking and full awareness of its deleterious health impact, smoking remains a significant contributor to morbidity and mortality. Some health impact of smoking may be improved by other forms of cigarettes than traditional combustion, especially for subjects unwilling or unable to stop smoking. As recently as 2020, one of heated tobacco products (HTP)(IQOS) was FDA Authorized as a 'Reduced Exposure' product. The available evidence to date allows to conclude that the IQOS system heats tobacco but does not burn it, which significantly reduces the production of harmful and potentially harmful chemicals. Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduced body's exposure to harmful or potentially harmful chemicals. There is also evidence indicating lower levels of inflammatory markers and improved vascular function associated with use of heated tobacco products. However, it is unknown whether the reduction in the exposure translates into potential reduction of harm within cardiovascular system, as compared to the traditional (combustion) cigarettes.\n\nThe evidence is of crucial importance for patients with cardiovascular diseases, medical community, and national health authorities planning evidence based policies regarding HTP\u002Fcigarettes.",[93,199,200],"Coronary Atherosclerosis","Nicotine Dependence","2024-12-16",{"date":203,"type":40},"2024-12-19",{"date":205,"type":40},"2023-02-09",{"date":207,"type":21},"2025-12-31",{"name":46,"class":47},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":88,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":48},"100490029","phase-4-optimal-antiplatelet-therapy-following-left-atrial-appendage-closure-in-dialyzed-patients-100490029","NCT05660811","Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients","Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure - Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study - PILOT","SAFE LAAC CKD","Inclusion Criteria:\n\n* Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days prior to randomization\n* End-stage renal disease treated with chronic haemodialysis or peritoneal dialysis\n* Participant's age 18 years or older at the time of signing the informed consent form\n* Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen\n* Participant is willing to sign the study informed consent form\n\nExclusion Criteria:\n\n* Indications to dual antiplatelet therapy other than left atrial appendage occlusion at the time of enrollment and\u002For predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization)\n* Indications to anticoagulation at the time of enrollment and\u002For predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism). Does not apply to anticoagulation used during dialysis\n* Known allergy to clopidogrel and\u002For acetylsalicylic acid precluding its administration as specified by the protocol\n* Peridevice leak \\>5mm on imaging study preceding enrollment\n* Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment\n* Life expectancy of fewer than 18 months\n* Participation in other clinical studies with experimental therapies at the time of enrollment and\u002For preceding 3 months\n* Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with a negative pregnancy test 24 hours before randomization if \\\u003C55 years old) or after surgical sterilization",{"count":218,"type":21},80,[140],"SAFE-LAAC CKD Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device in patients with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis",[222],"Atrial Fibrillation",[224,225,226,227,228],"atrial fibrillation","stroke","bleeding","left atrial appendage","dialysis","2024-06-24",{"date":231,"type":40},"2024-06-25",{"date":233,"type":40},"2022-09-28",{"date":75,"type":21},{"name":46,"class":47},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":88,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":48},"100319988","phase-4-optimal-antiplatelet-therapy-following-left-atrial-appendage-closure-100319988","NCT03445949","Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure","Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study","SAFE-LAAC","Inclusion Criteria:\n\n* Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization\n* Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization\n* Participant's age 18 years or older at the time of signing the informed consent form\n* Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen\n* Participant is willing to sign the study informed consent form\n\nExclusion Criteria:\n\n* Indications to dual antiplatelet therapy other than atrial fibrillation and\u002For left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization)\n* Indications to anticoagulation at the time of enrollment and\u002For predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism)\n* Known allergy to clopidogrel and\u002For acetylsalicylic acid precluding its administration as specified by the protocol\n* Any known inborn or acquired coagulation disorders\n* Peridevice leak \\>5mm on imaging study preceding enrollment\n* Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment\n* Life expectancy of fewer than 18 months\n* Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months\n* Chronic kidney disease stage IV and V\n* Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if \\\u003C55 years old) or after surgical sterilization",{"count":245,"type":21},200,[140],"SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device",[222],[250],"atrial fibrillation, stroke, bleeding, left atrial appendage","2023-07-10",{"date":253,"type":40},"2023-07-11",{"date":255,"type":40},"2018-01-23",{"date":257,"type":21},"2027-06-23",{"name":46,"class":47},""]