Evaluating the Effectiveness of the LifeVest Defibrillator and Improving Methods for Determining the Use of Implantable Cardioverter Defibrillators

Official Title: “Vest Prevention of Early Sudden Death and PREDiction of ICD Therapies”

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.

An ICD is a device designed to quickly detect a life-threatening, rapid heartbeat. Through a process called defibrillation, the ICD tries to convert an abnormal heart rhythm back to normal by delivering an electrical shock to the heart. The ICD continuously monitors heartbeats to ensure that they are normal, and it only delivers a shock to the heart when it senses a life-threatening arrhythmia. The LifeVest is a new, non-invasive, wearable defibrillator vest that is an alternative to an ICD. It consists of a vest that is worn over the chest and a monitor that is worn around the waist or shoulder. The LifeVest is less expensive than an ICD and does not require surgery. Currently, the LifeVest is approved by the Food and Drug Administration (FDA) for detecting and treating arrhythmias, but it is not known how effective it is in people who have recently had a heart attack.

This study is composed of two parts: the Vest Prevention of Early Sudden Death Trial (VEST) and a follow-up study called Prediction of ICD Therapies Study (PREDICTS). The purpose of VEST is to evaluate the effectiveness of the LifeVest defibrillator at preventing death caused by an arrhythmia in the 3 months after a heart attack. In PREDICTS, participants will be followed for several years after receiving an ICD or a Reveal monitor, which is an implantable heart monitoring device that does not treat arrhythmias. The purpose of PREDICTS is to improve the methods that doctors use to determine which patients will benefit the most from receiving an ICD.

This study will enroll people who have recently had a heart attack. While participants are in the hospital or clinic, they will undergo a baseline medical history review, physical exam, electrocardiogram (EKG) to measure electrical activity of the heart, and blood collection. Participants will then be randomly assigned to either wear the LifeVest for 3 months or receive usual care for 3 months. The LifeVest will continually collect and store heart rhythm information, and participants will transmit this data over the phone to study researchers on a weekly basis. At Month 1, participants will receive a follow-up phone call.

At Month 2, all participants will attend a study visit that will include repeat baseline testing, a signal-averaged electrocardiogram (SAECG) test to identify any scar tissue, a baroreflex sensitivity (BRS) test to measure heart rate changes in response to blood pressure changes, an echocardiogram (ECHO) of the heart, an exercise stress test, and quality of life questionnaires. Participants will wear a monitor for 24 hours after the study visit to record heart activity. A small amount of blood will be stored for future DNA analysis.

Participants whose heart function remains poor will receive an ICD implant, and all other participants will receive a Reveal monitoring device implant. The Reveal device will continuously monitor and record arrhythmias, but it will not provide any treatment. Every 1 to 3 months, participants will transmit their ICD or Reveal data by phone to researchers.

For 1 to 8 years, depending on when study entry occurs, participants will attend follow-up visits once a year for repeat testing. Study researchers will call participants periodically to monitor medication changes and medical problems.

The VEST/PREDICTS study was originally introduced as a single study with two phases (VEST and PREDICTS), with all consenting participants required to participate in both phases consecutively. Beginning with Version 2.0 of the protocol, the two phases were uncoupled resulting in three possible avenues for participant enrollment:

1. VEST/PREDICTS combined (V/P): Participants who meet inclusion criteria for VEST/PREDICTS combined enroll in both phases using one consent form (same as the original). This is the preferred enrollment strategy.

2. VEST only (V): Participants who meet inclusion criteria for VEST/PREDICTS combined but may not want to be in the three to five-year Predicts PREDICTS study, may opt to enroll in the 3-month VEST only study using the VEST consent

3. PREDICTS only (P): Participants who meet inclusion criteria for PREDICTS only may be enrolled while in the hospital for the qualifying MI, within the 7-day post discharge window, and up to 6 months post MI.

Intervention(s) in this Clinical Trial

• Device: LifeVest
  • The LifeVest is a non-invasive, wearable defibrillator vest that detects and treats arrhythmias.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will wear the LifeVest defibrillator for 3 months
• No Intervention: 2
  • Participants will receive usual care.

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: No

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Heart, Lung, and Blood Institute (NHLBI) NIH

Overall Clinical Trial Officials and Contacts

Jeffrey Olgin, MD Principal Investigator University of California, San Francisco  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00628966

Study ID Number: 534

ClinicalTrials.gov Identifier: NCT00628966

Health Authority: United States: Federal Government