Vest Prevention of Early Sudden Death Trial and VEST Registry
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
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: October 1, 2014
Last verified: October 2014
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
- incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
- adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: Yes ]
- compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1900 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446965
Show 65 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446965
Contacts
| Contact: Carol Maguire, RN | 415-476-5148 | cmaguire@medicine.ucsf.edu |
Show 65 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
No publications provided
| 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: | October 1, 2014 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Death Death, Sudden Infarction Myocardial Infarction Tachycardia, Ventricular Ventricular Dysfunction Ventricular Fibrillation Arrhythmias, Cardiac |
Cardiovascular Diseases Heart Diseases Ischemia Myocardial Ischemia Necrosis Pathologic Processes Tachycardia Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015