Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-09 @ 7:21 AM
Study NCT ID:
NCT00547794
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2007-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty in patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVERT-AF
Brief Summary:
The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.
Detailed Description:
* This is a prospective, randomized, double blinded, multicenter study
* Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)
* Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system
* Patients are followed at 1, 3, 6 and 12 months post implant
* Total # of centers - 20 centers
* Sample size - 180 patients
* Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)
* Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system
* Patients are followed at 1, 3, 6 and 12 months post implant
* Total # of centers - 20 centers
* Sample size - 180 patients
Study Oversight
Has Oversight DMC:
True
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?: