Clinical trials: Sudden Cardiac Death Primary Prevention
Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death
Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrillators in Dilated Cardiomyopathy
With the present study the investigators intend to identify the morphologic and electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy undergoing implantation of a defibrillator…
- Conditions
- Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Trial name
- EMOSIDD (NCT01378572)
- Where
- 3 sites in United States, Italy
- Volunteers
- 200 people
- Sponsor
- Catholic University of the Sacred Heart
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
S-ICD® System Post Approval Study
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
- Trial name
- NCT01736618
- Testing
- S-ICD System
- Where
- 87 sites in United States
- Volunteers
- 1,766 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Sudden Death
MIBG Scintigraphy as a Tool for Selecting Patients Requiring Implantable Cardioverter Defibrillator (ICD)
The aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator.
- Trial name
- MISTIC (NCT01185756)
- Testing
- MIBG for diagnostic purpose
- Where
- France
- Volunteers
- 330 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sudden Cardiac Arrest, Ventricular Arrythmia
Improve Sudden Cardiac Arrest Study
The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent…
- Trial name
- NCT02099721
- Testing
- ICD or CRT-D Device
- Where
- 93 sites in Argentina, Belarus and 14 more
- Volunteers
- 4,222 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute STEMI, Severe Left Ventricular Systolic Dysfunction (Disorder)
Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation
Patients presenting with STEMI and late revascularization can suffer from severe left ventricular dysfunction. Midterm and longterm mortality can be determined by the risk of fatal ventricular arrythmias.
- Trial name
- STEMI-MR (NCT03743935)
- Testing
- Gadolinium-enhanced cardiac MRI
- Where
- France
- Volunteers
- 12 people
- Sponsor
- University Hospital, Montpellier
Heart Failure With Reduced Ejection Fraction
Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification
A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction.
- Trial name
- PERFECT (NCT05539898)
- Testing
- ICD implantation
- Where
- Russia
- Volunteers
- 450 people
- Sponsor
- Astrakhan Federal Centre For Cardiac Surgery
Heart Failure, Primary Prevention of Sudden Cardiac Death
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in…
- Conditions
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Trial name
- DILEMMA (NCT05373940)
- Testing
- ICD implantation, No ICD implantation
- Where
- 19 sites in France
- Volunteers
- 730 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Prevention, Tachycardia, Ventricular
Survival of Patients With Primary Prophylactic ICD Indication
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD).
- Conditions
- Primary Prevention, Tachycardia, Ventricular, Sudden Cardiac Death
- Trial name
- SPIRIT-ICD (NCT00619593)
- Testing
- Intensified diagnostic and treatment measures following 1st appropriate ICD therapy, Standard follow-up
- Where
- 37 sites in Austria, Czechia and 9 more
- Volunteers
- 504 people
- Sponsor
- Biotronik SE & Co. KG
Coronary Heart Disease, Congestive Heart Failure
Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%.
- Conditions
- Coronary Heart Disease, Congestive Heart Failure, Ventricular Dysfunction, Low Cardiac Output
- Trial name
- SMART-ICD (NCT00524862)
- Testing
- Optimized medical therapy, Implantable Cardioverter Defibrillator
- Where
- 10 sites in Canada
- Volunteers
- 5,000 people
- Sponsor
- Unity Health Toronto
Myotonic Dystrophy 1, Sudden Cardiac Death
Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients
The aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy, including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in inducible patients, is able to improve…
- Trial name
- ACADEMY 1 (NCT03784586)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- University of Campania Luigi Vanvitelli
Chronic Heart Failure
Primary Prevention of Sudden Cardiac Death (PREV-DEATH)
The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD) is well demonstrated but pivotal studies have been published more than 10 years ago and implantation's conditions…
- Trial name
- PREV-DEATH (NCT02894580)
- Where
- France
- Volunteers
- 336 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Left Ventricular Systolic Dysfunction, Congestive Heart Failure
SCD-HeFT 10 Year Follow-up
No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years.
- Conditions
- Left Ventricular Systolic Dysfunction, Congestive Heart Failure, Ischemic and Non-ischemic Cardiomyopathy, Sudden Cardiac Death Primary Prevention
- Trial name
- SCD-HeFT10 Yr (NCT01058837)
- Where
- United States
- Volunteers
- 1,855 people
- Sponsor
- Seattle Institute for Cardiac Research
Heart Failure, Sudden Cardiac Death
CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the…
- Conditions
- Heart Failure, Sudden Cardiac Death, Atrial Fibrillation
- Trial name
- NCT00170313
- Testing
- Conducted AF-Response Algorithm (CAFR) On, Conducted AF-Response Algorithm (CAFR) Off
- Where
- 7 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Valvular Heart Disease, Implantable Cardioverter Defibrillator
Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
The prevalence of valvular heart disease is on the rise along with the aging society and the generalization of echocardiography.
- Conditions
- Valvular Heart Disease, Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Primary Prevention
- Trial name
- BEAT (NCT03590730)
- Testing
- ICD implantation
- Where
- 12 sites in South Korea
- Volunteers
- 12 people
- Sponsor
- Keimyung University Dongsan Medical Center
Cardiac Death
Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.
- Trial name
- DECREASE (NCT01217528)
- Testing
- device settings for group A, Device settings for group B
- Where
- 34 sites in Germany
- Volunteers
- 543 people
- Sponsor
- Abbott Medical Devices
Sudden Cardiac Death
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of…
- Trial name
- APPRAISE ATP (NCT02923726)
- Testing
- Arm 1 (ATP+Shock), Arm 2 (shock only)
- Where
- 134 sites in United States, Austria and 6 more
- Volunteers
- 2,692 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease, Myocardial Infarction
Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe
The "EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD)" is a modular research project to study the effectiveness of prophylactic ICDs in a…
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Dilated Cardiomyopathy, Implantable Defibrillator User
- Trial name
- EU-CERT-ICD (NCT02064192)
- Where
- 42 sites in Belgium, Bulgaria and 14 more
- Volunteers
- 2,285 people
- Sponsor
- University Medical Center Goettingen
Chagas Cardiomyopathy, Non-sustained Ventricular Tachycardia
Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death
The primary objective is to compare the efficacy of the treatment using implantable cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in the primary prevention of all-cause mortality in…
- Conditions
- Chagas Cardiomyopathy, Non-sustained Ventricular Tachycardia, At Least 10 Points in Rassi Risk Score for Death
- Trial name
- CHAGASICS (NCT01722942)
- Testing
- ICD implantation, amiodarone hydrochloride
- Where
- 20 sites in Brazil
- Volunteers
- 1,100 people
- Sponsor
- InCor Heart Institute
Heart Failure
Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan
The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing…
- Trial name
- SAVE-ICD (NCT03935087)
- Testing
- two-dimensional echocardiogram
- Where
- 6 sites in Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
Systolic Heart Failure, Sudden Cardiac Death
A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs)
The purpose of this study is to test the acceptability and feasibility of a "toolkit" of patient decision aids (PtDAs) for heart failure patients who are considering an ICD implant.
- Trial name
- NCT02026102
- Testing
- ICD Decision Aid Toolkit
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- University of Colorado, Denver