Clinical trials: ICD
Heart Failure, Ventricular Arrythmias
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices.
- Trial name
- NCT00746356
- Testing
- Testing of the autocapture features of the device
- Where
- 5 sites in United States
- Volunteers
- 128 people
- Sponsor
- Abbott Medical Devices
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast…
- Trial name
- ADVANCE_D (NCT00147277)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 925 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Myocardiopathies, Ischemia, Myocardial
Extracellular Matrix Marker of Arrhythmia Risk (EMMA)
Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.
- Conditions
- Myocardiopathies, Ischemia, Myocardial, Arrythmia, Death, Sudden, Cardiac
- Trial name
- EMMA (NCT00376532)
- Where
- United States
- Volunteers
- 63 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
Complication of Cardiac Defibrillator
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy.
- Trial name
- TARIFF (NCT01075516)
- Where
- 6 sites in Italy
- Volunteers
- 209 people
- Sponsor
- Abbott Medical Devices
Ventricular Fibrillation, Ventricular Flutter
SAFEty of Two Strategies of ICD Management at Implantation
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable…
- Conditions
- Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death
- Trial name
- SAFE-ICD (NCT00661037)
- Testing
- Implantable defibrillator
- Where
- Italy
- Volunteers
- 2,120 people
- Sponsor
- Boston Scientific Corporation
Heart Disease
Managed Ventricular Pacing ("MVP") Trial
The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and…
- Trial name
- MVP (NCT00281099)
- Testing
- ICD (Implantable Cardioverter Defibrillator)
- Where
- 73 sites in United States, Austria and 10 more
- Volunteers
- 1,031 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Cardiomyopathy, Heart Failure
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs)…
- Conditions
- Cardiomyopathy, Heart Failure, Cardiac Arrhythmia
- Trial name
- ULV (NCT02111993)
- Testing
- Standard Defibrillation Testing, Upper Limit of Vulnerability Testing
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Diego
Device Malfunction, ICD
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular…
- Conditions
- Device Malfunction, ICD, Pacemaker Lead Dysfunction
- Trial name
- ISEE (NCT04055740)
- Testing
- IVUS Imaging
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Chicago
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
Heart Failure, Systolic, Heart Failure
A Multicenter Trial of a Shared DECision Support Intervention for Patients Offered Implantable Cardioverter-DEfibrillators
The investigators goal is to assess real-world effectiveness of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model.
- Trial name
- NCT03374891
- Testing
- Educational video and/or handout
- Where
- United States
- Volunteers
- 790 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Heart Failure
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator…
- Trial name
- REDUCEhf (NCT00354159)
- Testing
- Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
- Where
- 52 sites in United States
- Volunteers
- 442 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Wound, Cardiac Arrhythmia
ZIPS Study - Zip Incision aPproximation vs. Suture
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.
- Trial name
- ZIPS (NCT02213510)
- Testing
- Zip Surgical Skin Closure Device, Standard Suture Closure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of California, San Diego
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
Venous Thrombosis
Study of Arixtra (Fondaparinux Sodium) to Prevent Blood Clots in Women Undergoing Abdominopelvic Surgery for Likely Gynecologic Malignancy
This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies.
- Trial name
- NCT00539942
- Testing
- Arixtra (fondaparinux sodium), Intermittent compression devices (ICD)
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Tachyarrhythmias, Sudden Cardiac Death
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
- Conditions
- Tachyarrhythmias, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT00940888
- Testing
- SJ4 connector and RV high voltage SJ4 lead
- Where
- United States
- Volunteers
- 1,701 people
- Sponsor
- Abbott Medical Devices
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Tachycardia, Ventricular
S-ICD® System IDE Clinical Study
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
- Trial name
- NCT01064076
- Testing
- S-ICD System
- Where
- 33 sites in United States, Netherlands and 2 more
- Volunteers
- 330 people
- Sponsor
- Boston Scientific Corporation
Adrenoleukodystrophy, Metachromatic Leukodystrophy
HSCT for High Risk Inherited Inborn Errors
Hematopoietic stem cell transplantation has proven effective therapy for individuals with adrenoleukodystrophy (ALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD, or Krabbe disease).
- Conditions
- Adrenoleukodystrophy, Metachromatic Leukodystrophy, Globoid Cell Leukodystrophy, Tay Sachs Disease
- Trial name
- NCT00383448
- Testing
- Clofarabine, Total body Irradiation, Melphalan
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Masonic Cancer Center, University of Minnesota