Evaluating the Effectiveness of the LifeVest Defibrillator and Improving Methods for Determining the Use of Implantable Cardioverter Defibrillators (VEST/PREDICTS)
|ClinicalTrials.gov Identifier: NCT00628966|
Recruitment Status : Unknown
Verified July 2011 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was: Active, not recruiting
First Posted : March 5, 2008
Last Update Posted : November 11, 2011
An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms. The LifeVest is a new non-invasive, wearable defibrillator that is an alternative to an ICD. This two-part study will evaluate the effectiveness of the LifeVest at reducing arrhythmias in people who have recently had a heart attack. The study will also develop methods to determine who may benefit the most from receiving an ICD.
NOTE: NHLBI only provides support for the PREDICTS part of the study.
|Condition or disease||Intervention/treatment||Phase|
|Death, Sudden, Cardiac Myocardial Infarction Arrhythmias, Cardiac||Device: LifeVest||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vest Prevention of Early Sudden Death and PREDiction of ICD Therapies|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
Participants will wear the LifeVest defibrillator for 3 months
The LifeVest is a non-invasive, wearable defibrillator vest that detects and treats arrhythmias.
No Intervention: 2
Participants will receive usual care.
- The primary outcome of the VEST study is sudden death mortality. The primary outcome of the PREDICTS study is the occurrence of ventricular arrhythmias. [ Time Frame: Measured at Months 2 to 3 for VEST, and Years 3 to 8 for PREDICTS ]
- Cardiovascular, all-cause, and other cause specific mortality; non fatal cardiovascular events; ventricular arrhythmias; adverse events; compliance; quality of life; resource utilization and cost [ Time Frame: Years 2 to 8 for PREDICTS ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628966
Show 60 Study Locations
|Principal Investigator:||Jeffrey Olgin, MD||University of California, San Francisco|