Clinical trials: ICD Indication
Cardiomyopathy
Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies
This is a pilot study to find a correlation between MRI and ICD therapy in patients with known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates with ventricular arrhythmias and the occurrence…
- Trial name
- NCT00312624
- Testing
- contrast-enhanced cardiac MRI
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Heart Failure, Arrhythmias, Cardiac
Heart Failure and Sudden Cardiac Death Japan Registry
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Trial name
- HINODE (NCT03185832)
- Testing
- CRT-D, ICD, PM / CRT-P
- Where
- 34 sites in Japan
- Volunteers
- 354 people
- Sponsor
- Boston Scientific Corporation
Congestive Heart Failure, Cardiac Resynchronization Therapy
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted…
- Trial name
- NCT00395642
- Testing
- Kronos LV-T, Lumax HF-T
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- Biotronik, Inc.
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure.
- Trial name
- NCT01117792
- Testing
- subcutaneous implantable defibrillator (S-ICD) system
- Where
- 8 sites in Italy, Netherlands and 2 more
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
ICD/CRT-D Indication
TD01 Master Study (Safety and Efficacy Study)
This clinical investigation is designed to confirm the safety and efficacy of the TD01 ICD lead.
- Trial name
- NCT02087189
- Testing
- First ICD/CRT-D implantation or upgrade from pacemaker
- Where
- 5 sites in Austria, Germany
- Volunteers
- 30 people
- Sponsor
- Biotronik SE & Co. KG
Tachycardia
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and…
- Trial name
- OPTION (NCT00729703)
- Testing
- Ovatio DR 6550
- Where
- 55 sites in United States, Belgium and 7 more
- Volunteers
- 462 people
- Sponsor
- LivaNova
Cardiac Disease
Lumax DX / Linox DX Evaluation
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system. No hypothesis has been defined.
- Trial name
- NCT01486836
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Biotronik SE & Co. KG
Sudden Cardiac Death
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Trial name
- Prediction (NCT00560768)
- Testing
- Ovatio VR 6250 or DR6550
- Where
- 30 sites in United States, Canada and 2 more
- Volunteers
- 198 people
- Sponsor
- LivaNova
Ventricular Arrhythmias
A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
- Trial name
- PRAETORIAN (NCT01296022)
- Testing
- Implantation of subcutaneous ICD, Implantation of transvenous ICD
- Where
- 39 sites in United States, Czechia and 4 more
- Volunteers
- 850 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Heart Failure
Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters
The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass) data to predict future cardiac events in heart…
- Trial name
- HF-RADAR (NCT01357408)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Thomas Jefferson University
Patients With an Indication for an ICD Implantation According to the Guidelines
Protecta Smart Analysis Register
ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent…
- Trial name
- ProSA (NCT01714921)
- Volunteers
- 504 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Shock
Programming Implantable Cardioverter Defibrillators in Patients With Primary Prevention Indication
Although shock therapy is effective in terminating ventricular tachycardia (VT), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life.
- Trial name
- PROVIDE (NCT00743522)
- Testing
- ICD/ CRT-D
- Where
- United States
- Volunteers
- 1,670 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
Implantable Cardiac Device. Patients With a NMR Indication
Patients With Implantable Cardiac Devices Requiring a Nuclear Magnetic Resonance
The general objective of this registry is to study the number of patients carrying an implantable cardiac device that have an indication for an imaging diagnosis based on nuclear magnetic resonance.
- Trial name
- RESONANCE (NCT04330898)
- Testing
- Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers
- Where
- 20 sites in Spain
- Volunteers
- 1,248 people
- Sponsor
- Trialance SCCL
Defibrillators, Tachycardia
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring…
- Trial name
- Educ@t (NCT01006746)
- Testing
- Remote monitoring by Home Monitoring system
- Where
- France
- Volunteers
- 571 people
- Sponsor
- Biotronik France
Heart Failure, Left Bundle-Branch Block
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication
Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately…
- Trial name
- CRTICD Dual LV (NCT01415024)
- Testing
- second LV lead in CRT
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Schuechtermann-Klinik
ICD Indication
Linox Smart S DX PME/Master Study
The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.
- Trial name
- NCT01090401
- Testing
- Linox smart S DX
- Where
- Germany
- Volunteers
- 116 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, CRT and/or ICD
Evaluation of Electrical and Hemodynamic Effects of Different Pacing Strategies in CRT Candidates
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients.
- Trial name
- NCT07032064
- Testing
- Sequential ventricular pacing at five sites
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Shanghai Zhongshan Hospital
Heart Failure
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and…
- Trial name
- TRI-V (NCT00746135)
- Testing
- Device Implantation
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices
Tachyarrhythmias, Atrial Fibrillation
OptiSense™ Performance in Detecting Atrial Episodes
The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW).
- Trial name
- SENSE-AF (NCT00870324)
- Testing
- OptiSense Lead, Tendril Lead
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices