Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST)

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2016 by University of California, San Francisco

Sponsor:

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: July 15, 2016

Last verified: July 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2011

Last Updated Date

July 15, 2016

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

December 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sudden death mortality [ Time Frame: three months after myocardial infarction ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01446965 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Vest Prevention of Early Sudden Death Trial and VEST Registry

Official Title ^ICMJE

Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator

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-threatening arrhythmias.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Infarction
Ventricular Dysfunction
Sudden Death
Ventricular Tachycardia
Ventricular Fibrillation

Intervention ^ICMJE

Device: wearable defibrillator

LifeVest wearable defibrillator

Other Names:

LifeVest
wearable cardioverter-defibrillator
WCD
WD

Study Arm (s)

Experimental: Wearable defibrillator
subjects will use a wearable defibrillator for three months following myocardial infarction

Intervention: Device: wearable defibrillator
No Intervention: Conventional treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2300

Estimated Completion Date

December 2017

Estimated Primary Completion Date

December 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:
1. If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
2. If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
3. 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.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carol Maguire, RN

415-476-5148

Carol.Maguire@ucsf.edu

Listed Location Countries ^ICMJE

United States, Germany, Poland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01446965

Other Study ID Numbers ^ICMJE

90D0114

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

University of California, San Francisco

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Zoll Medical Corporation

Investigators ^ICMJE

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

Information Provided By

University of California, San Francisco

Verification Date

July 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top