Clinical trial NCT01448005: LifeVest Post-CABG Registry
Official title: Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sudden Cardiac Death
Ventricular Fibrillation
Ventricular Tachycardia
Ventricular Dysfunction
Myocardial Ischemia
Keywords: Coronary Artery Bypass Grafting
Resuscitation
Sudden Cardiac Death
Ventricular Dysfunction
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: number of patients who experience sudden cardiac death
timeFrame: three months
Secondary outcomes:
measure: number of patients who experience inappropriate shocks
timeFrame: three months
measure: hours per day of wearable defibrillator use
timeFrame: three months
measure: number of patients who experience sudden cardiac arrest
timeFrame: three months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Heart and Vascular Institute
state: California
city: Atlanta
country: United States
facility: Saint Joseph's Health System, Inc.
state: Georgia
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Houston
country: United States
facility: Texas Heart Institute, St. Luke's Episcopal Hospital
state: Texas
city: Richmond
country: United States
facility: Chippenham Johnston-Willis Medical Center
state: Virginia
Study officials:
affiliation: Zoll Medical Corporation
name: Steven J Szymkiewicz, MD
role: STUDY_DIRECTOR
References: