Clinical trials: Defibrillator
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia, Cardiovascular Diseases
Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial
The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in…
- Conditions
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia, CVD
- Trial name
- ABCD (NCT00583297)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- CardioDx
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
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Sudden Cardiac Death, Sudden Cardiac Arrest
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident…
- Trial name
- WED-HED (NCT02481206)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 31 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zoll Medical Corporation
Heart Failure, Congestive
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart…
- Trial name
- NCT00279955
- Testing
- Cardiac Resynchronization Therapy Device
- Where
- 93 sites in United States
- Volunteers
- 1,024 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Diabetes Mellitus
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous…
- Conditions
- Tachycardia, Diabetes Mellitus, Cardiovascular Disease
- Trial name
- MADIT S-ICD (NCT02787785)
- Testing
- Subcutaneous Implantable Cardioverter Defibrillator
- Where
- 49 sites in United States, Germany and 5 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
Arrhythmia
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart.
- Trial name
- NCT00035490
- Testing
- Azimilide Dihydrochloride
- Where
- 142 sites in United States, Belgium and 7 more
- Volunteers
- 633 people
- Sponsor
- Forest Laboratories
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Clinical Investigation of the Medtronic Concerto™ Device
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268320
- Testing
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Where
- 51 sites in United States, Austria and 10 more
- Volunteers
- 270 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Ventricular Fibrillation
Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.
- Conditions
- Tachycardia, Ventricular Fibrillation, Ventricular Flutter
- Trial name
- NCT01856491
- Testing
- RELIANCE 4-FRONT™ Passive Fixation lead implantation
- Where
- 11 sites in Germany, Israel and 1 more
- Volunteers
- 167 people
- Sponsor
- Boston Scientific Corporation
Ventricular Fibrillation, Ventricular Tachycardia
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular…
- Trial name
- NCT00399217
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) system, ICD
- Where
- United Kingdom
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
Implantable Defibrillator User
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
- Trial name
- MRI Ready IDE (NCT02787291)
- Testing
- Ellipse VR ICD and Durata/Optisure lead
- Where
- 32 sites in United States, Hungary and 3 more
- Volunteers
- 227 people
- Sponsor
- Abbott Medical Devices
Implantable Cardioverter Defibrillator(ICD)
To Evaluate the Delivery Timing Safety and Efficacy of AntiTachycardia Pacing (BIO|ATP)
To compare Treatment Group (settings of Early Multiple ATP) and Control Group (settings of extended detection time for the conventional ATP) in Japanese patients, and confirm their safety and efficacy
- Trial name
- BIO|ATP (NCT05426785)
- Testing
- 1:1 ratio for Treatment Group and Control Group
- Where
- Japan
- Volunteers
- 398 people
- Sponsor
- Biotronik SE & Co. KG
Myocardial Infarction, Arrhythmia, Ventricular
MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart.
- Conditions
- Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
- Trial name
- NCT00305240
- Testing
- T Wave Alternans Test
- Where
- 47 sites in United States
- Volunteers
- 656 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiovascular Disease
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for…
- Trial name
- NCT00856349
- Testing
- Therapy Programming Report (TPR)
- Where
- 104 sites in United States, Argentina and 10 more
- Volunteers
- 4,384 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrythmia, Implatable Cardioverter Defibrillation, Lead
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped\&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT)…
- Trial name
- NAVIGATOR (NCT03279484)
- Testing
- NAVIGO 4LV lead implant
- Where
- 38 sites in France, Germany and 4 more
- Volunteers
- 317 people
- Sponsor
- MicroPort CRM
Tachycardia, Ventricular
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System.
- Trial name
- EFFORTLESS (NCT01085435)
- Testing
- S-ICD System
- Where
- 44 sites in Czechia, Denmark and 8 more
- Volunteers
- 994 people
- Sponsor
- Boston Scientific Corporation
Arrhythmia, Tachycardia, Ventricular
Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS
Primary objective: to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions.
- Conditions
- Arrhythmia, Tachycardia, Ventricular, Ventricular Fibrillation
- Trial name
- ICARIOS (NCT00232297)
- Testing
- SSR149744C
- Where
- 8 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Sanofi