Evaluating the Effectiveness of the LifeVest Defibrillator and Improving Methods for Determining the Use of Implantable Cardioverter Defibrillators (VEST/PREDICTS)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628966
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|Principal Investigator:||Jeffrey Olgin, MD||University of California, San Francisco|