Status:
COMPLETED
Vest Prevention of Early Sudden Death Trial and VEST Registry
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Zoll Medical Corporation
Conditions:
Myocardial Infarction
Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-thre...
Detailed Description
In patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. Wearable defibrillators may reduce sudden death ...
Eligibility Criteria
Inclusion
- Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)
- LV ejection fraction ≤35% determined at the following time point:
- If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
- If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
- If CABG is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG
- Age ≥ 18 years
Exclusion
- Existing ICD or indication for an ICD at the time of screening
- Existing unipolar pacemakers/leads
- Chronic renal failure requiring hemodialysis after hospital discharge
- Chest circumference too small or too large for LifeVest garment\*
- Participants discharged to an institutional setting with an anticipated stay \> 7 days
- Pregnancy
- Inability to consent
- Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
2348 Patients enrolled
Trial Details
Trial ID
NCT01446965
Start Date
July 1 2008
End Date
May 31 2019
Last Update
January 20 2021
Active Locations (71)
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1
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
2
Cardiovascular Consultants Heart Center
Fresno, California, United States, 93720
3
Salinas Valley Memorial Healthcare System
Salinas, California, United States, 93901
4
University of California, San Francisco
San Francisco, California, United States, 94143