[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"implantable-defibrillator-user\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:implantable-defibrillator-user":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,64,92,114,139],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100327542","effectiveness-of-exercise-after-an-icd-100327542",false,"NCT03544489","Effectiveness of Exercise After an ICD","Clinical Effectiveness of Exercise After an ICD (E-ICD)","E-ICD","Inclusion Criteria:\n\n* ICD implantation for primary or secondary prevention of sudden cardiac arrest, -ability to read, speak and write English,-\n* access to a reliable phone for 6 months after study entry,\n* able to ambulate without assist devices for at least 5-10 minutes\u002Fday\n* greater than 18 years of age.\n\nExclusion Criteria:\n\n* current diagnosis of serious mental disorder,\n* regular non-medical use of illicit drugs (opiates, cocaine, amphetamines, etc.), -unstable angina, myocardial infarction, ICD shock or heart surgery within previous 3 months\n* pregnancy\n* concurrent participation in an exercise program \\> 5 days\u002Fweek.","ALL","18 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will test an exercise intervention (E-ICD) following an implantable cardioverter defibrillator.",[27,28,29],"Heart Arrest","Implantable Defibrillator User","Physical Activity","RECRUITING","2026-04-21",{"date":33,"type":34},"2026-04-23","ACTUAL",{"date":36,"type":34},"2025-05-01",{"date":38,"type":21},"2029-06-30",{"name":40,"class":41},"University of Washington","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":42},"100588151","remote-alert-pathway-to-optimize-care-of-cardiac-implantable-electrical-devices-100588151","NCT06937658","Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices","RAPTOR-CIED","Inclusion Criteria:\n\n1. Adult aged \\> 18 years\n2. Clinically stable by investigator assessment\n3. Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous\u002Fextravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)\n4. CIED is from one of the 4 major CIED manufacturers in the US market (99% of implants in the US): Medtronic, Boston Scientific, Abbott, Biotronik\n5. Currently enrolled in remote monitoring as part of standard of care\n6. Primary clinical electrophysiology follow-up at the enrolling center\n7. Understands spoken and written English, Spanish, or Portuguese\n8. Has sufficient cognitive function to answer standardized questions about study rationale and procedures.\n\nExclusion Criteria:\n\n1. Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED\n2. Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)\n3. Participation in another study related to novel CIED technology or remote monitoring.",{"count":51,"type":21},120,[24],"The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).\n\nThe study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Feasibility Phase of the study.",[55,28],"Pacemaker DDD","2026-01-05",{"date":58,"type":34},"2026-01-07",{"date":36,"type":34},{"date":61,"type":21},"2026-06-30",{"name":63,"class":41},"Beth Israel Deaconess Medical Center",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100518995","self-management-interventions-after-an-icd-shock-100518995","NCT06037785","Self-Management Interventions After an ICD Shock","Biobehavioral Intervention to Reduce PTSD After ICD Shock","Inclusion Criteria:\n\n1. ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),\n2. receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;\n3. able to read, speak and write English;\n4. access to online resources and telephone for study duration.\n\nExclusion Criteria:\n\n1. current diagnosis of PTSD, schizophrenia or bipolar disorder;\n2. Short BLESSED score \\>6 indicating cognitive dysfunction \\[73\\];\n3. age \\\u003C18 years;\n4. AUDIT-C score ≥4 for alcohol use;\n5. regular non-medical use of illicit drugs",{"count":72,"type":21},60,[24],"This study, \"Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock,\" addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30\u002Fgroup). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.",[28,76,77,78,79],"Stress Reaction","Ptsd","Stress Management","Social Cognitive Theory",[81,82,83],"implantable cardioverter defibrillator","ptsd","stress management","2025-09-22",{"date":86,"type":34},"2025-09-24",{"date":88,"type":34},"2024-10-01",{"date":90,"type":21},"2026-07-31",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":42},"100545934","investigation-of-the-audible-icd-alert-tone-100545934","NCT06388382","Investigation of the Audible ICD Alert Tone","Investigation of the Audible Alert Tone in ICD Patients with Subcutaneous Cardioverter Defibrillators","Inclusion Criteria:\n\n* patient equipped with a subcutaneous ICD\n* willing to participate\n\nExclusion Criteria:\n\n* S-ICD implantation within the past 3 weeks\n* patient is deaf","15 Years","100 Years",{"count":102,"type":21},150,"OBSERVATIONAL","Ability of ICD patients to hear the audible ICD alert is being assessed.",[28],"2024-11-06",{"date":108,"type":34},"2024-11-08",{"date":88,"type":34},{"date":111,"type":21},"2025-05-30",{"name":113,"class":41},"Universitätsklinikum Köln",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":124,"studyType":103,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100503479","end---vt-cohort-study-100503479","NCT05835791","END - VT Cohort Study","Prospective Cohort for the sEcoNDary Prevention of Ventricular Tachycardia in Patients With Cardiomyopathies (END-VT) Study","END VT","Inclusion Criteria:\n\n1. Documented sustained ventricular arrhythmia (\\>30 seconds as documented by an ECG, cardiac monitor, AED, and\u002For intracardiac pacemaker\u002FICD electrograms (EGMs);\n2. First (new) diagnosis of VT;\n3. Presence of or plan for ICD implant during index hospitalization;\n4. Diagnosis of cardiomyopathy (ie. ICM, hypertrophic, dilated, restrictive, arrhythmogenic cardiomyopathy, or other scar),\n5. ICD clinic follow-up planned, and\n6. Age \\>18 years old\n\nExclusion Criteria:\n\n1\\) Patients with VT due to a reversible cause",{"count":123,"type":21},2454,"3 Years","Ventricular tachycardia (VT) is a life-threatening cardiac rhythm disturbance which leads to sudden cardiac death (SCD), ventricular fibrillation, electrical storm, hemodynamic collapse, and syncope. VT patients with cardiomyopathy (diseased\u002Fscarred cardiac muscle) have the highest risk of SCD (\\\u003C1-4%) and recurrent VTs (15-35%). Although an implantable cardiac defibrillator (ICD) is the most effective treatment option to prevent SCD, it does not eliminate it. Without VT prevention, recurrent VT and ICD shocks may increase the risk of heart failure and death.\n\nThe primary objective is to determine the optimal treatment strategy to maximize event-free survival among cardiomyopathy patients with ventricular tachycardia (VT) by the creation of a prospective, multicenter, longitudinal cohort. Also, the investigators will evaluate the epidemiology of VT, adherence to guidelines, safety, effectiveness, and cost-effectiveness of current treatment options for secondary prevention of VT in the real-world Canadian VT population.",[127,28,128],"Ventricular Tachycardia","ICD","2024-07-15",{"date":131,"type":34},"2024-07-16",{"date":133,"type":34},"2024-01-12",{"date":135,"type":21},"2029-04-30",{"name":137,"class":41},"Nova Scotia Health Authority",3,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":147,"studyType":103,"phases":4,"briefSummary":148,"conditions":149,"keywords":154,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":42},"100350035","french-national-registry-of-patients-with-tetralogy-of-fallot-and-implantable-cardioverter-defibrillator-100350035","NCT03837574","French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator","DAI-T4F","Inclusion Criteria:\n\n* tetralogy of Fallot\n* implantable cardioverter defibrillator\n\nExclusion Criteria:\n\n* age \\\u003C 18 years",{"count":102,"type":21},"20 Years","National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.",[150,28,151,152,153],"Tetralogy of Fallot","Congenital Heart Disease","Sudden Cardiac Death","Ventricular Arrythmia",[155,81,156,157,158],"tretalogy of fallot","congenital heart disease","sudden cardiac death","ventricular arrhythmia","2019-02-09",{"date":161,"type":34},"2019-02-12",{"date":163,"type":34},"2010-12-01",{"date":165,"type":21},"2030-12-31",{"name":167,"class":41},"Paris Sudden Death Expertise Center"]