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

University of Pittsburgh

Status and phase

Completed

Phase 4

Conditions

Atrial Fibrillation

Treatments

Other: rhythm control via pharmacologic, electrical or ablative therapies

Other: rate control via CRT-D and AVN ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01233648

0601113

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 3.
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
Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
Willing to provide written informed consent
Are expected to survive for 6 month of study participation
Able to tolerate an urgent thoracotomy
Able to tolerate < 1 mg dexamethasone sodium phosphate (steroid)

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