Clinical Trials Directory

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.