N/A
Completed N=2,348
Vest Prevention of Early Sudden Death Trial and VEST Registry
Myocardial Infarction · Ventricular Dysfunction · Sudden Death · Ventricular Tachycardia
Source: ClinicalTrials.gov NCT01446965 ↗
Enrolled (actual)
2,348
Serious AEs
31.6%
Results posted
Jan 2021
Primary outcomePrimary: Sudden Death Mortality — 25; 19 Participants
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-threatening arrhythmias.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sudden Death Mortality |
25; 19 | — |
| SECONDARY All Cause Mortality |
48; 38 | — |
| SECONDARY Compliance With Wearable Defibrillator Use |
18 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01446965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.