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Completed

NCT Number: NCT01446965

Vest Prevention of Early Sudden Death Trial and VEST Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Med. Uniklinik Heidelberg, Heidelberg, Deutschland, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wearable defibrillator

Device

LifeVest wearable defibrillator

Other names: LifeVest, wearable cardioverter-defibrillator, WCD, WD

Primary outcomes

  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 outcomes

  1. All Cause Mortality

    Time frame: three months after myocardial infarction

    All deaths, due to any cause

  2. Compliance With Wearable Defibrillator Use

    Time frame: three months after myocardial infarction

    daily wear time of the device

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Zoll Medical Corporation

Registry information

Official study title

Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)

Acronym: VEST

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2011
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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