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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction; Ventricular Dysfunction; Sudden Death; Ventricular Tachycardia; Ventricular Fibrillation	Device: wearable defibrillator	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	2300 participants
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
Study Start Date :	July 2008
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Sudden death mortality [ Time Frame: three months after myocardial infarction ]

Secondary Outcome Measures :

1. Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ]
2. incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ]
3. adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
4. compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01446965 History of Changes
Other Study ID Numbers:	90D0114
First Posted:	October 5, 2011
Last Update Posted:	November 9, 2017
Last Verified:	November 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