[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"implantable-cardioverter-defibrillator-icd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:implantable-cardioverter-defibrillator-icd":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,73,108,138,173],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100640844","comparison-of-the-effects-of-different-upper-extremity-aerobic-exercise-training-protocols-on-arm-functional-capacity-in-patients-with-heart-failure-with-cardiac-implantable-electronic-devices-100640844",false,"NCT07592494","Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices","Inclusion Criteria:\n\n* Patients aged 18 and over with heart failure who are receiving Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)\n* At least 3 months have passed since device implantation and there have been no complications at the last device control\n* Being in New York Heart Association (NYHA) Class II-III\n* Patients without cooperation problems\n* Patients who volunteer to participate in the study\n\nExclusion Criteria:\n\n* Patients who have previously participated in a cardiac rehabilitation program and those who have completed less than 1 year since the program,\n* Patients with a primary diagnosis of cardiomyopathy and those with heart failure secondary to cardiomyopathy,\n* Patients with a history of shoulder pathologies that may restrict upper extremity movement before device implantation (such as severe pain around the shoulder, edema, or shoulder dislocation that restricts upper extremity movement),\n* Patients with a history of shoulder surgery (patients with limitations in range of motion),\n* Patients who have undergone mastectomy on the affected side or a cerebrovascular event resulting in arm involvement,\n* Patients with decompensated heart failure,\n* Patients with a history of ICD-incompatible shock,\n* Patients with a history of unstable angina pectoris, acute myocardial infarction, or cardiac surgery within the last 3 months,\n* Patients who have experienced acute atrial fibrillation, ventricular tachycardia, and ventricular fibrillation within the last 3 months,\n* Patients with actively treated malignancy or collagen tissue disease receiving systemic steroids\n* Patients with chronic kidney disease undergoing dialysis where volume load is unstable,\n* Persistent ventricular arrhythmias during baseline cardiopulmonary exercise testing.","ALL","18 Years",{"count":18,"type":19},36,"ESTIMATED","INTERVENTIONAL",[22],"NA","1. To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF.\n2. To investigate whether high-intensity intermittent upper extremity aerobic exercise training provides a more effective improvement in upper extremity functional capacity compared to moderate-intensity continuous upper extremity aerobic exercise training.\n3. To determine the effectiveness of different types of upper extremity aerobic exercise training compared to lower extremity aerobic training alone in individuals with CIED and HF.",[25,26,27],"Heart Failure","Implantable Cardioverter Defibrillator (ICD)","Cardiac Resynchronization Therapy Devices",[29,30,25,31,32,33],"Implantable Cardioverter Defibrillator","Cardiac Resynchronization Therapy Device","Upper Extremity Aerobic Exercise","Cardiac Rehabilitation","Physiotherapy and Rehabilitation","NOT_YET_RECRUITING","2026-05-11",{"date":37,"type":38},"2026-05-18","ACTUAL",{"date":35,"type":19},{"date":41,"type":19},"2027-05-11",{"name":43,"class":44},"Erol Olcok Corum Training and Research Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100567385","to-test-an-e-health-educational-intervention-patients-with-an-icd-100567385","NCT06667505","To Test an e-Health Educational Intervention Patients With an ICD","To Co-develop and Test an eHealth Intervention to Improve Knowledge, Attitude and Experience in Patients Living With an Implantable Cardioverter Defibrillator","CHOICE-ICD","Inclusion Criteria:\n\n* Patients with heart failure awaiting or with an ICD (no time restriction on implantation)\n* No cognitive impairment\n\nCaregivers:\n\n* Have contact with the patient at least 5 times per week.\n* Be physically and mentally capable of participation (self-assessment)\n\nHealthcare professionals:\n\n* Daily care of patients with heart failure and an implantable cardioverter defibrillator\n* Involved in the care of a patient using the Choice-ICD intervention\n\nExclusion Criteria:\n\n* Patients, judged by their Cardiologist as physically or mentally unsuitable to complete the study.\n* Patients or caregivers lacking capacity to give consent.\n* Patients who have known pregnancy\n* Caregivers who's patient is unwilling to take participate",{"count":54,"type":19},256,[22],"Role of the implantable cardioverter defibrillator (ICD) is to monitor heart rate and discharge a small electrical discharge or shock if the heart rate becomes life threatening. Patients and family members have requested more information about their ICD, how it works and how to live well with the device. This study will build on previous research by designing, in collaboration with patients, family members and professionals, an online resource to provide important information that can lower anxiety and concerns, and improve quality of life. The CHOICE-ICD resource will be easy to use, incorporating games and quizzes to encourage engagement, up to date information appropriate to each patient's needs, as well as animation clips, virtual reality, and short patient videos. CHOICE-ICD will be made available to 64 patients, in addition to normal care, awaiting or with a recently implanted ICD in Belfast and Glasgow. Patients will use the resource for 3 months. Patients and family members will then be asked to complete questionnaires and participate in semi-structured interviews. This study will develop 1st UK online resource providing information to enable patients to have greater choice and control in their care.",[26],[59,60,61],"Implantable cardioverter defibrillatior","e-Health intervention","patient education","RECRUITING","2026-04-28",{"date":65,"type":38},"2026-05-05",{"date":67,"type":38},"2025-08-11",{"date":69,"type":19},"2026-12-01",{"name":71,"class":44},"University of Ulster",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":20,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100620186","optimal-settings-for-anti-tachycardia-pacing-atp-on-icd-100620186","NCT07354347","Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD","Optimal ATP Settings in the VT Zone for New Implantable Cardioverter Defibrillator (ICD) Implantation (DAN-ATP)","DAN-ATP","Inclusion Criteria:\n\n\\- ICD implantation for primary or secondary prophylactic indication\n\nExclusion Criteria:\n\n* None\n* Patients can actively opt out of participation in the study",{"count":82,"type":19},3980,[22],"This is a pragmatic, two-group, cluster randomized trial designed to compare strategies for the Anti Tachycardia Pacing (ATP)-setting in the ventricular tachyarrhythmias (VT) zone when implanting a new implantable cardioverter defibrillator (ICD) in patients with heart disease in hospitals in Denmark.\n\nThe strategies are: \"Burst\" or \"Ramp\" after 1. ATP (which is always burst) in VT zone. VT zone is defined between 180-249 (up to 269 in special cases) heartbeats per minute.\n\nThe ICD will give either:\n\nBurst: The ICD is programmed to give ATP with 4 bursts. Or Ramp: The ICD is programmed to give ATP with 1 burst and 3 ramps.\n\nThe participating hospitals will be assigned to one of two intervention strategies for periods of 4-months. The given intervention will follow the patient\u002FICD throughout the life time of the ICD, but with the possibility to reprogram at any time (intention to treat).\n\nIt is calculated that the study needs a total of 398 events (second to fourth ATP), which is estimated to require 3980 implanted ICDs. The participants will be followed until the end of the ICD life, which is estimated to be around 10 years.",[86,26,87,88],"Heart Disease","Heart Rhythm Disorders","Ventricular Tachyarrhythmias",[90,91,92,93,29,94,95,96,97],"Heart failure","ICD","ATP","Anti Takykardi Pacing","cluster randomisation","heart rhythm disorder","ventricular tachyarrhythmias","VT","2026-01-26",{"date":100,"type":38},"2026-01-27",{"date":102,"type":19},"2026-02-01",{"date":104,"type":19},"2041-07-31",{"name":106,"class":44},"Rigshospitalet, Denmark",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":115,"targetDuration":117,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100607528","the-magnasafe-2-registry-assessing-the-risks-of-magnetic-resonance-imaging-in-three-patient-groups-100607528","NCT07189728","The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups","The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups: (1) an MRI at a Magnet Field Strength of 3-tesla, (2) a \"Mixed-vendor\" or a Same Vendor \"Mixed-component\" Platform at 1.5-tesla or 3-tesla, or (3) a System With an Abandoned, Epicardial, or Fractured Lead at 1.5-tesla.","Inclusion Criteria:\n\nPatients will be included in the registry if they fulfill all the following criteria:\n\n1. Age of 18 years or older\n2. Able to provide informed consent for entry in the research registry\n3. Have a CIED from any manufacturer implanted after 2001\n4. Have cardiac leads from any manufacturer without an implant date limitation\n5. Documentation that the patient's ordering physician has determined that an MRI at 1.5-tesla or 3.0-tesla of any anatomic region is clinically indicated without an acceptable alternative imaging technology\n6. The patient is scheduled for that imaging procedure\n7. MRI will be performed for clinical purposes, and not for the purpose of entry into this research protocol\n8. In addition, groups within the protocol require that an enrolled patient will have:\n\n   1. An NMRC CIED scheduled for MRI at 3.0-tesla with a CIED that is not MRC at that field strength.\n   2. A \"mixed-vendor\" or same vendor \"mixed-component\" system that is NMRC because the generator and lead combination are not labeled as MRC for use in the MR-environment.\n   3. A CIED and abandoned lead, a fractured cardiac lead, an epicardial lead, or a subcutaneous array.\n\n      Exclusion Criteria:\n\n      Patients will not be included in the registry if they fulfill any of the following criteria:\n\n   \u003C!-- -->\n\n   1. A generator battery at the elective replacement indicator (ERI)\n   2. Renal insufficiency (GFR \\\u003C45 cc\u002Fmin)\n   3. In addition, all standard clinical exclusion criteria for MRI in patients without a cardiac device will be observed.\n   4. Standard clinical exclusion criteria include pregnancy, severe claustrophobia (not responsive to pre-procedure medications), morbid obesity (abdominal diameter of greater than 60 cm), and the presence of ferro-magnetic metallic objects (such as intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils)\n\n      \\-",{"count":116,"type":19},1500,"6 Months","OBSERVATIONAL","SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been published by the Heart Rhythm Society, and the Medicare National Coverage Determination (NCD) has been modified to provide coverage for these patients (CAG-00399R4). However, for patients with an abandoned, epicardial, or fractured cardiac lead or subcutaneous array, with a \"mixed-vendor\" or same-vendor \"mixed-component\" CIED, or those undergoing MRI at 3.0-tesla with a device not labelled as MRI-conditional (MRC) for use at 3-tesla, the risks of MRI have not been determined.\n\nHypothesis: For patients with an MRC or NMRC pacemaker or defibrillator and specific indications or circumstances not presently addressed, the risks of MRI do not increase.\n\nPurpose: The MagnaSafe-2 Registry is designed to determine the risks of MRI in patients with limited MRI access not previously addressed in peer-reviewed literature and to improve access for approximately 70% of whom are predicted to have a future clinical need for MRI.\n\nStudy Design: A prospective registry of patients undergoing clinically indicated MRI. The protocol is being developed in collaboration with the FDA's Center for Devices and Radiological Health, and an Investigational Device Exemption is being requested for event reporting and monitoring. Also, \"Coverage with Evidence Development (CED)\" has been requested from CMS.\n\nEnrollment: Eligible patients are 18 years or older and have a MRC or NMRC pacemaker system from any manufacturer, (after 2001), with leads from any manufacturer (without date restriction), and if the ordering physician has determined that MRI is clinically indicated, the imaging method of choice, and NOT performed for the purpose of research. Exclusions are a leadless pacemaker, a device battery at \"elective replacement indicator,\" or renal insufficiency (GFR \\\u003C45 cc\u002Fmin). All participants will be required to provide informed consent for the collection of data.\n\nMethods: Patients will be enrolled in the registry at up to 30 clinical centers with: (1) an NMRC pacing system scheduled for MRI at a magnet field strength of 3-tesla, (2) an NMRC system due to a \"mixed-vendor\" or a same vendor \"mixed-component\" platform at 1.5-tesla or 3-tesla, or (3) an MRC or NMRC pacing system and an abandoned, epicardial, or fractured lead at 1.5-tesla.\n\nPrimary Endpoints: A new cardiac arrhythmia noted during the MRI scan, or a Troponin-T elevation (\\>upper limit of normal) at 18-24 hours post-MRI scan compared to baseline (obtained within 30 days before the MRI scan), Troponin-T levels pre-MRI. Secondary Endpoints: Death, generator or lead failure requiring immediate replacement, loss of pacing capture (pacing-dependent patients), partial or full generator-electrical reset, pacing lead threshold increase of ≥1.0 V, a P-wave amplitude decrease of ≥50%, an R-wave amplitude decrease of ≥50%, and a pacing lead impedance change of ≥50 ohms from baseline.\n\nSample Size: Using an event rate limit of ≤1%, 500 cases will be needed in each group to yield a 95% confidence interval of 0 to 1.0% if no events are observed. When a total of 500 cases have been enrolled in one group, enrollment in the other groups may be continued at the discretion of the investigators. The estimated study duration is 5 years, including enrollment and data analysis.\n\nClinical Implications and Impact: The anticipated results will support an amendment to the current HRS Expert Consensus Statement (2017) and Medicare NCD (April 2018) for the patient groups in the study.",[121,122,26],"Pacemakers","MRI Imaging",[124,125,126,127,128],"pacemaker","MRI","implantable cardioverter defibrillator","abandoned cardiac leads","3-tesla","2025-09-22",{"date":131,"type":38},"2025-09-24",{"date":133,"type":19},"2026-01-01",{"date":135,"type":19},"2031-01-01",{"name":137,"class":44},"The Scripps Research Institute",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":20,"phases":147,"briefSummary":149,"conditions":150,"keywords":156,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"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":146,"type":19},2000,[148],"PHASE4","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.",[151,152,153,26,154,155],"Heart Failure With Reduced Ejection Fraction (HFrEF)","Sudden Cardiac Death","Ventricular Arrhythmia","Beta-blocker Therapy","Cardiomyopathy",[157,158,91,126,159,160,161,162],"arrhythmia","heart failure","ICD shock","carvedilol","metoprolol succinate","beta-blocker","2025-09-12",{"date":165,"type":38},"2025-09-18",{"date":167,"type":38},"2025-08-17",{"date":169,"type":19},"2031-07-01",{"name":171,"class":44},"University of Rochester",13,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":180,"targetDuration":182,"studyType":118,"phases":4,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":4},"100605002","observational-belgian-registry-of-implanted-ev-icd-to-evaluate-parameters-and-complications-of-the-new-device-in-real-world-settings-100605002","NCT07156851","Observational BELgian Registry of Implanted EV-ICD to Evaluate Parameters and Complications of the New Device in Real World Settings","BELIEVE","Inclusion Criteria:\n\n* At least 18 years old\n* Previous or planned EV-ICD implantation (successful or not)\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients who did not undergo any step of the implantation procedure",{"count":181,"type":19},100,"15 Years","The goal of this observational study is to follow all patients implanted with extravascular implantable cardioverter-defibrillators (EV-ICDs) in Belgium throughout the lifetime of the devices. The main goal of the study is to keep track of:\n\n* all parameters of the device\n* complications\n* arrhythmia detection and therapy delivery\n* clinical endpoints (quality of life, cardiac and infectious events) Participants who underwent or will undergo an EV-ICD implantation as part of their regular medical care will be asked if data can be collected from their medical record. No additional tasks are required for the study.",[26],[186,187],"Extravascular implantable cardioverter-defibrillator","EV-ICD","2025-08-27",{"date":190,"type":38},"2025-09-05",{"date":192,"type":19},"2025-11",{"date":194,"type":19},"2040-07-01",{"name":196,"class":44},"AZ Sint-Jan AV"]