LifeVest Post-CABG Registry

This study is currently recruiting participants.

Verified April 2013 by Zoll Medical Corporation

Sponsor:

Information provided by (Responsible Party):

Zoll Medical Corporation

ClinicalTrials.gov Identifier:

NCT01448005

First received: October 4, 2011

Last updated: April 24, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 4, 2011

Last Updated Date

April 24, 2013

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

number of patients who experience sudden cardiac death [ Time Frame: three months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01448005 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

number of patients who experience inappropriate shocks [ Time Frame: three months ] [ Designated as safety issue: Yes ]
hours per day of wearable defibrillator use [ Time Frame: three months ] [ Designated as safety issue: No ]
number of patients who experience sudden cardiac arrest [ Time Frame: three months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LifeVest Post-CABG Registry

Official Title ^ICMJE

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Sudden Cardiac Death
Ventricular Fibrillation
Ventricular Tachycardia
Ventricular Dysfunction
Myocardial Ischemia

Intervention ^ICMJE

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

Study Group/Cohort (s)

wearable defibrillator use

subjects will use a wearable defibrillator

Intervention: Device: wearable defibrillator (LifeVest)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Steven J Szymkiewicz, MD

412-968-3333 ext 4400

sszymkiewicz@zoll.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01448005

Other Study ID Numbers ^ICMJE

90D0107

Has Data Monitoring Committee

Responsible Party

Zoll Medical Corporation

Study Sponsor ^ICMJE

Zoll Medical Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Steven J Szymkiewicz, MD

Zoll Medical Corporation

Information Provided By

Zoll Medical Corporation

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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