Conditions: Atrial Fibrillation Heart Failure
Keywords: Atrial Fibrillation Heart Failure AV Node ablation Cardiac pacemaker Antiarrhythmic drug
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 27
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).

Detailed description:
Epidemiologic studies have shown that 70-80% of patients with atrial fibrillation are older than 65 years of age. Drug therapy for atrial fibrillation is not effective or not tolerated in many elderly patients, for both rate or rhythm strategies. Preliminary data from AVN ablation and pacemaker therapy demonstrated this strategy is highly effective in controlling symptoms among patients who have failed numerous drug therapy. Quality of life is improved while hospital admission and office visits are reduced.

Pilot Study Design

* All patients will be 1:1 randomized to standard-care drug therapy (American College of Cardiology/American Heart Association Guideline, 2006) or AV node ablation and pacemaker therapy
* For patients randomized to AVN ablation, there will be a 1:1 sub-randomization to conventional right ventricular apex pacing or cardiac resynchronization therapy (biventricular pacing)
* All patients will be followed at 2 and 6 months from the time of randomization in the pilot study.
* A total of 60 patients from 5-15 clinical sites will be enrolled during an active recruiting period of 12 months for the pilot study.

Arms:
arm 1: FDA approved rate and rhythm control drugs arm 2: AV Node ablation and device implant

Interventions: intervention 1: FDA approved rate and rhythm control drugs intervention 2: AV Node ablation and device implant
Intervention descriptions: intervention 1: Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.

Rate Control:

Beta-Blocker:

* metoprolol
* atenolol
* carvedilol

Calcium Channel Blocker:

* verapamil
* diltiazem

Rhythm Control:

* procainamide
* quinidine
* disopyramide
* propafenone
* flecainide
* sotalol
* dofetilide
* amiodarone intervention 2: Pacing Systems:

* Enpusle Premarket Approval Number (PMA#) P980035
* EnRhythm PMA# P980035
* Adapta PMA# P980035

Cardiac Resynchronization Therapy (CRT) Pacing Systems:

\- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031

Implantable Cardioverter-Defibrillator (ICD) Pacing Systems:

* EnTrust PMA# P980016
* Virtuoso PMA# P980016

ICD CRT Pacing Systems:

* InSync Maximo PMA# P980016
* InSync Sentry PMA# P890003
* Concerto PMA# P980016

Protocol document: