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

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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


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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