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

Tracking Information
First Submitted Date ICMJE	October 3, 2011
First Posted Date ICMJE	October 5, 2011
Last Update Posted Date	November 9, 2017
Study Start Date ICMJE	July 2008
Estimated Primary Completion Date	May 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 4, 2011)	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; (submitted: October 4, 2011)	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; (submitted: July 15, 2016)	2300
Original Estimated Enrollment ICMJE; (submitted: October 4, 2011)	1900
Estimated Study Completion Date	December 2018
Estimated Primary Completion Date	May 2018 (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: 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
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	November 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP