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

This study is ongoing, but not recruiting participants.

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: April 14, 2017

Last verified: April 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2011

Last Updated Date

April 14, 2017

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 ]

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 ]
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 ]

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
Intervention Model: Parallel Assignment
Masking: Single (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 Arms

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

Active, not 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany, Poland, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01446965

Other Study ID Numbers ^ICMJE

90D0114

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

PRS Account

University of California, San Francisco

Verification Date

April 2017

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

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