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

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01446965

First Posted: October 5, 2011

Last Update Posted: April 17, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Zoll Medical Corporation

Information provided by (Responsible Party):

University of California, San Francisco

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: Single (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:

Genetics Home Reference related topics: catecholaminergic polymorphic ventricular tachycardia

MedlinePlus related topics: Heart Attack

Genetic and Rare Diseases Information Center resources: Paroxysmal Ventricular Fibrillation

U.S. FDA Resources

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: LifeVest wearable cardioverter-defibrillator WCD WD
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

Information from the National Library of Medicine

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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:
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	October 3, 2011
First Posted:	October 5, 2011
Last Update Posted:	April 17, 2017
Last Verified:	April 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

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