Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT01448005
Status:
TERMINATED
Last Update Posted:
2017-12-06
First Post:
2011-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LifeVest Post-CABG Registry
Sponsor:
Zoll Medical Corporation
Organization:
Study Overview
Official Title:
Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: