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LifeVest Post-CABG Registry

NCT ID: NCT01448005

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-10-31

Brief Summary

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This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.

Detailed Description

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Conditions

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Sudden Cardiac Death Ventricular Fibrillation Ventricular Tachycardia Ventricular Dysfunction Myocardial Ischemia

Keywords

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Coronary Artery Bypass Grafting Resuscitation Sudden Cardiac Death Ventricular Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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wearable defibrillator use

subjects will use a wearable defibrillator

wearable defibrillator (LifeVest)

Intervention Type DEVICE

A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.

Interventions

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wearable defibrillator (LifeVest)

A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.

Intervention Type DEVICE

Other Intervention Names

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LifeVest wearable cardioverter defibrillator wearable automatic external defibrillator

Eligibility Criteria

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Inclusion Criteria

* Patients who have undergone CABG surgery during current hospitalization
* Patients who have an ejection fraction ≤ 35% following the surgery.
* Patients who have dilated cardiomyopathy or prior myocardial infarction.
* Patients who are prescribed a wearable defibrillator following surgery.
* Patient who are at least 18 years old.

Exclusion Criteria

* Patients who have an active ICD.
* Patients who have an active unipolar pacemaker.
* Patients having a chest circumference over 56 inches or under 26 inches.
* Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
* Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
* Patients participating in another clinical study with mortality as the primary endpoint.
* Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).
* Patients who have decided to forgo resuscitation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven J Szymkiewicz, MD

Role: STUDY_DIRECTOR

Zoll Medical Corporation

Locations

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Sutter Heart and Vascular Institute

Sacramento, California, United States

Site Status

Saint Joseph's Health System, Inc.

Atlanta, Georgia, United States

Site Status

Washington Adventist Hospital

Takoma Park, Maryland, United States

Site Status

Texas Heart Institute, St. Luke's Episcopal Hospital

Houston, Texas, United States

Site Status

Chippenham Johnston-Willis Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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90D0107

Identifier Type: -

Identifier Source: org_study_id