LifeVest Post-CABG Registry

NCT01448005 | Terminated

• 1 other identifier: 90D0107
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Sudden Cardiac Death; Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Dysfunction; Myocardial Ischemia

Keywords

Coronary Artery Bypass Grafting; Resuscitation; Sudden Cardiac Death; Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• number of patients who experience sudden cardiac death

  three months

Secondary Outcomes (3)

• number of patients who experience inappropriate shocks

  three months

• hours per day of wearable defibrillator use

  three months

• number of patients who experience sudden cardiac arrest

  three months

Study Arms (1)

wearable defibrillator use

subjects will use a wearable defibrillator

Device: wearable defibrillator (LifeVest)

Interventions

wearable defibrillator (LifeVest) DEVICE

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

Also known as: LifeVest, wearable cardioverter defibrillator, wearable automatic external defibrillator

wearable defibrillator use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (5)

Sutter Heart and Vascular Institute

Sacramento, California, 95819, United States

Location

Saint Joseph's Health System, Inc.

Atlanta, Georgia, 30342, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Texas Heart Institute, St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Chippenham Johnston-Willis Medical Center

Richmond, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular; Ventricular Dysfunction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Tachycardia; Cardiac Conduction System Disease; Vascular Diseases

Study Officials

• Steven J Szymkiewicz, MD

  Zoll Medical Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (5)