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Evaluating the Effectiveness of the LifeVest Defibrillator and Improving Methods for Determining the Use of Implantable Cardioverter Defibrillators (VEST/PREDICTS)

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: NCT00628966
Recruitment Status : Unknown
Verified July 2011 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2008
Last Update Posted : November 11, 2011
Sponsor:
Collaborators:
Medtronic
Zoll Medical Corporation
General Electric
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:

An implantable cardioverter defibrillator (ICD) is a small device that is implanted in the chest and uses electrical shocks to control arrhythmias, which are abnormal heart rhythms. The LifeVest is a new non-invasive, wearable defibrillator that is an alternative to an ICD. This two-part study will evaluate the effectiveness of the LifeVest at reducing arrhythmias in people who have recently had a heart attack. The study will also develop methods to determine who may benefit the most from receiving an ICD.

NOTE: NHLBI only provides support for the PREDICTS part of the study.


Condition or disease Intervention/treatment Phase
Death, Sudden, Cardiac Myocardial Infarction Arrhythmias, Cardiac Device: LifeVest Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vest Prevention of Early Sudden Death and PREDiction of ICD Therapies
Study Start Date : July 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: 1
Participants will wear the LifeVest defibrillator for 3 months
Device: LifeVest
The LifeVest is a non-invasive, wearable defibrillator vest that detects and treats arrhythmias.
No Intervention: 2
Participants will receive usual care.



Primary Outcome Measures :
  1. The primary outcome of the VEST study is sudden death mortality. The primary outcome of the PREDICTS study is the occurrence of ventricular arrhythmias. [ Time Frame: Measured at Months 2 to 3 for VEST, and Years 3 to 8 for PREDICTS ]

Secondary Outcome Measures :
  1. Cardiovascular, all-cause, and other cause specific mortality; non fatal cardiovascular events; ventricular arrhythmias; adverse events; compliance; quality of life; resource utilization and cost [ Time Frame: Years 2 to 8 for PREDICTS ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Table 1.1 VEST/PREDICTS combined and VEST only Participants

INCLUSION CRITERIA

  1. Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)1
  2. LV ejection fraction ≤35% determined ≥ 8° after MI (or ≥ 8° after a PCI)
  3. Age >18 years

EXCLUSION CRITERIA

  1. Clinically significant valve disease (critical AS or MS; severe MR/AI/TR/PI likely to require surgery in the next year)
  2. Patients with planned CABG within 2 months of screening for enrollment
  3. Existing ICD or indication for an ICD at the time of screening
  4. Contraindication to eventual ICD
  5. Existing unipolar pacemakers/leads
  6. Non-cardiac condition likely to cause death within 3 years
  7. Chronic renal failure requiring hemodialysis after hospital discharge
  8. Chest circumference too small or too large for LifeVest garment*
  9. Participants discharged to an institutional setting with an anticipated stay > 7 days
  10. Pregnancy
  11. Inability to consent
  12. Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.

Table 1.2 PREDICTS only Participants

INCLUSION CRITERIA

  1. Patients identified in the hospital or within 6 months after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)1
  2. LV ejection fraction ≤35% determined ≥ 8° after MI (or ≥ 8° after a PCI) if enrolled within 7 days of discharge from qualifying MI hospitalization or if enrolled >7 days from discharge EF measured on the most recent determination prior to enrollment from qualifying MI hospitalization (≤ 6 months)
  3. Age >18 years

EXCLUSION CRITERIA

  1. Clinically significant valve disease (critical AS or MS; severe MR/AI/TR/PI likely to require surgery in the next year)
  2. Patients with planned CABG within 2 months of screening for enrollment
  3. Existing ICD or prior cardiac arrest, sustained VT or VF.
  4. Contraindication to eventual ICD
  5. Non-cardiac condition likely to cause death within 3 years
  6. Chronic renal failure requiring hemodialysis after hospital discharge
  7. Participants discharged to an institutional setting with an anticipated stay of > 7 days
  8. Pregnancy
  9. Inability to consent
  10. Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628966


  Hide Study Locations
Locations
United States, Alaska
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
United States, Arizona
Cardiovascular Associates of Mesa
Mesa, Arizona, United States, 85206
United States, Arkansas
Little Rock Cardiology
Little Rock, Arkansas, United States, 72211
United States, California
Cardiovascular Consultants Heart Center
Fresno, California, United States, 93720
Salinas Valley Memorial Healthcare System
Salinas, California, United States, 93901
Univ. of Calif. San Diego - ACC Cardiology Clinic
San Diego, California, United States, 92103
San Diego Cardiac Center
San Diego, California, United States, 92123
University of California, San Francisco
San Francisco, California, United States, 94143
St. Joseph's Medical Center
Stockton, California, United States, 95204
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, Florida
University of Florida
Gainsville, Florida, United States, 32610
Watson Clinic Center for Research, Inc.
Lakeland, Florida, United States, 33805
Heart and Vascular Institute of Florida
Safety Harbor, Florida, United States, 34695
United States, Illinois
Advocate Christ Hospital
Oak Lawn, Illinois, United States, 60453
Lutheran General
Park Ridge, Illinois, United States, 60068
United States, Indiana
The Heart Group/Deaconess Hospital
Evansville, Indiana, United States, 47713
Parkview Research Center
Fort Wayne, Indiana, United States, 46805
St. Francis Hospital and Health Centers
Indianapolis, Indiana, United States, 46237
United States, Iowa
McFarland Clinic PC
Ames, Iowa, United States, 50010
United States, Kentucky
Universtiy of Kentucky Gill Heart Institute
Lexington, Kentucky, United States, 40536
Louisville Cardiology Medical Group
Louisville, Kentucky, United States, 40207
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
University of Massachusettes Memorial
Worcester, Massachusetts, United States, 01655
United States, Missouri
Liberty Hospital
Liberty, Missouri, United States, 64069
United States, New Mexico
Presbyterian Heart Group
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Associates in Cardiology
Albany, New York, United States, 12205
Montefiore Medical Center
Bronx, New York, United States, 10467
SJH Cardiology Asscociates
Liverpool, New York, United States, 13088
Long Island Jewish Hospital
New Hyde Park, New York, United States, 11040
Lenox Hill Hospital
New York City, New York, United States, 10075
Mount Sinai Hospital
New York, New York, United States, 10029
Huntington Hospital
NY, New York, United States, 11743
University Cardiovascular Assoc (Rochester)
Rochester, New York, United States, 14626
Stony Brook University
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina, at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wakeforest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
The Ohio State University, Davis Heart and Lung Institute
Columbus, Ohio, United States, 43210
North Ohio Heart Center-North Ohio Research
Elyria, Ohio, United States, 44035
United States, Oklahoma
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Endovascular Research, LLC
Springfield, Oregon, United States, 97477
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown Medical School - Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
South Carolina Heart Center
Columbia, South Carolina, United States, 29204
Pee Dee Cardiology
Florence, South Carolina, United States, 29506
United States, Tennessee
Wellmont Holston Valley (Prev Cardiovascular Associates, PC)
Kingsport, Tennessee, United States, 37660
Mercy Medical Center West
Knoxville, Tennessee, United States, 37934
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75226
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Health Sciences Center @ Houston
Houston, Texas, United States, 77030
United States, Washington
Cardiac Study Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Dean Foundation for Health, Research and Education Inc.
Madison, Wisconsin, United States, 53715
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
ProHealth Care
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Medtronic
Zoll Medical Corporation
General Electric
Investigators
Principal Investigator: Jeffrey Olgin, MD University of California, San Francisco

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00628966     History of Changes
Other Study ID Numbers: 534
1U01HL089458 ( U.S. NIH Grant/Contract )
1U01HL089145 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: July 2011

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Heart Attack
ICD
Risk Stratification
Arrhythmia

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Death
Arrhythmias, Cardiac
Death, Sudden
Death, Sudden, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Arrest