LifeVest Post-CABG Registry

• Sponsor: Zoll Medical Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01448005
• Collaborator: (none)
• Enrollment: 69
• Locations: 5
• Duration (Months): 44
• Patients Per Site: 13.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sudden Cardiac Death; Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Dysfunction; Myocardial Ischemia	Device: wearable defibrillator (LifeVest)

Study Design

• Study Type: Observational
• Actual Enrollment: 69 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
wearable defibrillator use subjects will use a wearable defibrillator	Device: wearable defibrillator (LifeVest); A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.; Other Names: LifeVest wearable cardioverter defibrillator wearable automatic external defibrillator

Outcome Measures

Primary Outcome Measures

1. number of patients who experience sudden cardiac death [three months]

Secondary Outcome Measures

1. number of patients who experience inappropriate shocks [three months]

2. hours per day of wearable defibrillator use [three months]

3. number of patients who experience sudden cardiac arrest [three months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sutter Heart and Vascular Institute	Sacramento	California	United States	95819
2	Saint Joseph's Health System, Inc.	Atlanta	Georgia	United States	30342
3	Washington Adventist Hospital	Takoma Park	Maryland	United States	20912
4	Texas Heart Institute, St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
5	Chippenham Johnston-Willis Medical Center	Richmond	Virginia	United States	23225

Sponsors and Collaborators

• Zoll Medical Corporation

Investigators

• Study Director: Steven J Szymkiewicz, MD, Zoll Medical Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zoll Medical Corporation
• ClinicalTrials.gov Identifier: NCT01448005
• Other Study ID Numbers: 90D0107
• First Posted: Oct 6, 2011
• Last Update Posted: Dec 6, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Zoll Medical Corporation: Coronary Artery Bypass Grafting; Resuscitation; Sudden Cardiac Death; Ventricular Dysfunction
• Additional relevant MeSH terms: Tachycardia; Myocardial Ischemia; Tachycardia, Ventricular; Ventricular Dysfunction; Death, Sudden, Cardiac; Ventricular Fibrillation; Ischemia; Death

Study Results

No Results Posted as of Dec 6, 2017