LifeVest Post-CABG Registry

Myocardial Ischemia Clinical Trial

Official title:

Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01448005
• Other study ID #: 90D0107
• Status: Terminated
• Phase: N/A
• First received: October 4, 2011
• Last updated: December 4, 2017
• Start date: February 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2017
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Death
• Death, Sudden, Cardiac
• Ischemia
• Myocardial Ischemia
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Dysfunction
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• wearable defibrillator (LifeVest)
A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.

Locations

Country	Name	City	State
United States	Saint Joseph's Health System, Inc.	Atlanta	Georgia
United States	Texas Heart Institute, St. Luke's Episcopal Hospital	Houston	Texas
United States	Chippenham Johnston-Willis Medical Center	Richmond	Virginia
United States	Sutter Heart and Vascular Institute	Sacramento	California
United States	Washington Adventist Hospital	Takoma Park	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who experience sudden cardiac death		three months
Secondary	number of patients who experience inappropriate shocks		three months
Secondary	hours per day of wearable defibrillator use		three months
Secondary	number of patients who experience sudden cardiac arrest		three months