Trials / Terminated
TerminatedNCT00547794
AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF
AVERT-AF: Atrio-VEntricular Junction Ablation Followed by Resynchronization Therapy in Patients With Congestive Heart Failure and Atrial Fibrillation
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 14 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2010-08-01
- Completion
- 2010-11-01
- First posted
- 2007-10-23
- Last updated
- 2019-02-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00547794. Inclusion in this directory is not an endorsement.