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Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01446965
First received: October 3, 2011
Last updated: April 14, 2017
Last verified: April 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Myocardial Infarction Ventricular Dysfunction Sudden Death Ventricular Tachycardia Ventricular Fibrillation | Device: wearable defibrillator | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Sudden death mortality [ Time Frame: three months after myocardial infarction ]
Secondary Outcome Measures:
- Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ]
- incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ]
- adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
- compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
| Estimated Enrollment: | 2300 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Wearable defibrillator
subjects will use a wearable defibrillator for three months following myocardial infarction
|
Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
|
| No Intervention: Conventional treatment |
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 by providing immediate detection and treatment of ventricular arrhythmias. This study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01446965
Show 71 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446965
Show 71 Study Locations
Sponsors and Collaborators
University of California, San Francisco
Zoll Medical Corporation
Investigators
| Principal Investigator: | Jeffrey E Olgin, MD | University of California, San Francisco |
| Study Director: | Byron K Lee, MD | University of California, San Francisco |
| Principal Investigator: | Mark J Pletcher, MD, MPH | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01446965 History of Changes |
| Obsolete Identifiers: | NCT00628966 |
| Other Study ID Numbers: |
90D0114 |
| Study First Received: | October 3, 2011 |
| Last Updated: | April 14, 2017 |
Keywords provided by University of California, San Francisco:
|
myocardial infarction, acute myocardial infarction ventricular dysfunction death, sudden, cardiac death, sudden death |
ventricular tachycardia ventricular fibrillation defibrillation, electric cardioversion, electric electric countershock defibrillators, external |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Death Tachycardia Ventricular Dysfunction Tachycardia, Ventricular Ventricular Fibrillation Death, Sudden |
Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arrhythmias, Cardiac |
ClinicalTrials.gov processed this record on June 23, 2017