Vest Prevention of Early Sudden Death Trial and VEST Registry (VEST)
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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. |
ClinicalTrials.gov Identifier: NCT01446965 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 5, 2011
Last Update Posted
: November 9, 2017
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Sponsor:
University of California, San Francisco
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
University of California, San Francisco
Tracking Information | ||||||||||
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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 |
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 |
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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 |
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Condition ICMJE |
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Intervention ICMJE | Device: wearable defibrillator
LifeVest wearable defibrillator
Other Names:
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Study Arms |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||
Estimated Enrollment ICMJE |
2300 | |||||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |