Clinical trials: Implantable Cardioverter Defibrillators
Heart Failure, Congestive
Home Monitoring in Cardiac Resynchronisation Therapy
In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem.
- Trial name
- HomeCARE (NCT00376116)
- Testing
- Cardiac resynchronisation therapy, Implantable cardioverter-defibrillator
- Where
- 82 sites in Austria, Czechia and 8 more
- Volunteers
- 513 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmias, Cardiac, Heart Diseases
Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)
This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter…
- Conditions
- Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Implantable Cardioverter Defibrillator
- Trial name
- SHIELD-2 (NCT01464476)
- Testing
- Azimilide Dihydrochloride
- Where
- 138 sites in United States, Belgium and 11 more
- Volunteers
- 240 people
- Sponsor
- Forest Laboratories
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Implantable Cardioverter-Defibrillators, Ventricular Fibrillation
Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring
In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner.
- Conditions
- Implantable Cardioverter-Defibrillators, Ventricular Fibrillation, Tachycardia, Ventricular
- Trial name
- ECOST (NCT00989417)
- Testing
- ACTIVATION of HOME MONITORING
- Where
- France
- Volunteers
- 473 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization…
- Trial name
- InContact (NCT01200381)
- Testing
- Quarterly remote follow ups and remote monitoring, Quarterly remote follow ups + additional phone calls and remote monitoring, Quarterly in clinic follow ups and remote monitoring
- Where
- 17 sites in Germany
- Volunteers
- 210 people
- Sponsor
- Abbott Medical Devices
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
Congestive Heart Failure, Coronary Artery Disease
MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)
The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure.
- Conditions
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- Trial name
- NCT00054678
- Testing
- MyoCell™, MyoCath™
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Bioheart, Inc.
Tachycardia
Safety and Performance Study of the Reliance 4-Front Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.
- Trial name
- NCT01772576
- Testing
- Reliance 4-Front lead implantation
- Where
- 15 sites in Austria, China and 9 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Trial name
- NCT07091916
- Testing
- Defibrillation using the Extravascular ICD
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Focus Whether After Implant Pre-AICD Video Was Helpful
LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD)
The purpose of this trial was to develop the initial sections of a video/DVD cassette that provided guidance about mastering stressful situations for patients who had been informed that they need an implantable…
- Trial name
- AICD (NCT01686490)
- Testing
- Video/workbook for patients about to receive an AICD, LiveSkills Video/Workbook for patients about to receive an AICD
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Williams LifeSkills
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Tachycardia, Ventricular Fibrillation
First Arrhythmia Collection of Transvenous and Simultaneous Subcutaneous Implantable Defibrillator Data
The purpose of this clinical study is to collect simultaneous, multiple view cardiac signals representing both transvenous ICDs (T-ICD) and sensing vectors from the subcutaneous implantable defibrillator system (S-ICD).
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- FACTS (NCT01161589)
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 142 people
- Sponsor
- Boston Scientific Corporation
Ventricular Arrythmia
Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.
- Trial name
- EFICAZ (NCT03632057)
- Testing
- Fixed Tilt (65%), Fixed Pulse Width
- Where
- 2 sites in Spain
- Volunteers
- 779 people
- Sponsor
- Abbott Medical Devices
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia, Coronary Artery Disease
Substrate Modification in Stable Ventricular Tachycardia in Addition to Implantable Cardioverter Defibrillator (ICD) Therapy
The main objective of this study is to compare the time from randomization to the first recurrence of any ventricular tachycardia (VT) in patients undergoing VT ablation (for stable VTs) and substrate ablation (for unstable VTs)…
- Conditions
- Ventricular Tachycardia, Coronary Artery Disease, Left Ventricular Dysfunction
- Trial name
- VTACH (NCT00919373)
- Testing
- Substrate modification, VT ablation, ICD Implantation
- Where
- 16 sites in Czechia, Denmark and 2 more
- Volunteers
- 110 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD)
PREPARE - Primary Prevention Parameters Evaluation
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter…
- Conditions
- Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular, Syncope
- Trial name
- NCT00279279
- Testing
- Implanted Device
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Implantable Defibrillator User
Plexa ICD Lead Registry
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
- Trial name
- NCT03103503
- Where
- 28 sites in United States
- Volunteers
- 901 people
- Sponsor
- Biotronik, Inc.
Heart Failure
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality. (MADIT-CRT IDE: NCT00180271)
- Trial name
- MADIT-CRT PAR (NCT01294449)
- Testing
- MADIT-CRT ICD, MADIT-CRT CRT-D
- Where
- United States
- Volunteers
- 394 people
- Sponsor
- Boston Scientific Corporation
ICD, Sudden Cardiac Death
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e.
- Conditions
- ICD, Sudden Cardiac Death, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- THORN (NCT01594112)
- Where
- 55 sites in France
- Volunteers
- 512 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Defibrillators, Implantable
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an…
- Conditions
- Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy
- Trial name
- PREEMPT-HF (NCT03579641)
- Testing
- HeartLogic Sensors
- Where
- 88 sites in United States, Australia and 11 more
- Volunteers
- 2,184 people
- Sponsor
- Boston Scientific Corporation