Clinical trials: Primary Prevention of Sudden Cardiac Arrest
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
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
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
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.
- Trial name
- LSS of 4-SITE (NCT01596595)
- Where
- 111 sites in United States, Australia and 1 more
- Volunteers
- 1,820 people
- Sponsor
- Boston Scientific Corporation
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
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
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
Primary Prevention of Sudden Cardiac Arrest
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.
- Trial name
- MADIT-RIT (NCT00947310)
- Testing
- Standard ICD programming, High rate cutoff, Long delay
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Boston Scientific Corporation
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
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
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
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
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
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