LifeVest Post-CABG Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Zoll Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT01448005
First received: October 4, 2011
Last updated: January 13, 2014
Last verified: January 2014

October 4, 2011
January 13, 2014
February 2011
July 2014   (final data collection date for primary outcome measure)
number of patients who experience sudden cardiac death [ Time Frame: three months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01448005 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
LifeVest Post-CABG Registry
Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Sudden Cardiac Death
  • Ventricular Fibrillation
  • Ventricular Tachycardia
  • Ventricular Dysfunction
  • Myocardial Ischemia
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
wearable defibrillator use
subjects will use a wearable defibrillator
Intervention: Device: wearable defibrillator (LifeVest)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Steven J Szymkiewicz, MD 412-968-3333 ext 4400 sszymkiewicz@zoll.com
United States
 
NCT01448005
90D0107
No
Zoll Medical Corporation
Zoll Medical Corporation
Not Provided
Study Director: Steven J Szymkiewicz, MD Zoll Medical Corporation
Zoll Medical Corporation
January 2014

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