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

• Sponsor: University of California, San Francisco
• Collaborator: Zoll Medical Corporation
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2302 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)
• Actual Study Start Date: July 2008
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Wearable defibrillator; subjects in the Device Group will receive a wearable cardioverter-defibrillator plus guideline-directed medical therapy	Device: wearable defibrillator; LifeVest wearable defibrillator; Other Names: LifeVest; wearable cardioverter-defibrillator; WCD; WD
No Intervention: Conventional treatment; subjects in the Control Group will receive guideline-directed medical therapy alone

Outcome Measures

Primary Outcome Measures :

1. Sudden death mortality [ Time Frame: three months after myocardial infarction ]
   For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.

Secondary Outcome Measures :

1. Cardiovascular, all-cause, and other cause specific mortality [ Time Frame: three months after myocardial infarction ]
   All deaths, due to any cause
2. incidence of ventricular arrhythmias [ Time Frame: three months after myocardial infarction ]
   Evidence of new or worsening symptoms or physical examination signs of ventricular arrhythmia based on one or more of the following: a direct review of the ECG tracing, a documented electrical or pharmacologic cardioversion attempt, the initiation or elevation of the dose of a medication or the implantation of a device for the purpose of controlling the arrhythmia or complications of the arrhythmia.
3. adverse events attributable to wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
   any undesirable sign, symptom or medical condition occurring after initiation of the study treatment that is considered to be related to study treatment
4. compliance with wearable defibrillator use [ Time Frame: three months after myocardial infarction ]
   daily wear time of the device

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

  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

Additional Information:

Linked to VEST/PREDICTS registration: NCT00628966 

Publications:

Olgin JE, Pletcher MJ, Vittinghoff E, Wranicz J, Malik R, Morin DP, Zweibel S, Buxton AE, Elayi CS, Chung EH, Rashba E, Borggrefe M, Hue TF, Maguire C, Lin F, Simon JA, Hulley S, Lee BK; VEST Investigators. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. 2018 Sep 27;379(13):1205-1215. doi: 10.1056/NEJMoa1800781.

• 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: June 6, 2019
• Last Verified: June 2019

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; Tachycardia, Ventricular; Ventricular Dysfunction; Ventricular Fibrillation; Death, Sudden; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease