Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

University of Pittsburgh1 site in 1 country52 target enrollmentJune 2006

ConditionsAtrial Fibrillation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: University of Pittsburgh
Enrollment: 52
Locations: 1
Primary Endpoint: AF burden
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

November 2015

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pittsburgh

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
•In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
•Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
•Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
•Not taking or able to be taken off all type I/III antiarrhythmic medications.
•Taking Coumadin so as to maintain an INR of between 2 and
•A Class I or IIa ICD indication
•NYHA Class III/IV within 1 month of baseline
•Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
•Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline

Exclusion Criteria

•Having self-terminating or interminable AF
•Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
•Post-heart transplant (patients on heart transplant list for the first time are not excluded)
•Having mechanical right heart valve
•Having an existing CRT or atrial therapy device(s)
•Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
•Having primary valvular disease and indicated for valve repair or replacement
•Having a previous AV node ablation
•Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
•Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control