Trials / Terminated
TerminatedNCT01448005
LifeVest Post-CABG Registry
Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 69 (actual)
- Sponsor
- Zoll Medical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Sudden Cardiac Death
- Ventricular Fibrillation
- Ventricular Tachycardia
- Ventricular Dysfunction
- Myocardial Ischemia
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | wearable defibrillator (LifeVest) | A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention. |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2014-09-01
- Completion
- 2014-10-01
- First posted
- 2011-10-06
- Last updated
- 2017-12-06
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01448005. Inclusion in this directory is not an endorsement.