AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Pacing and AV Node Ablation Compared to Drug Therapy in Symptomatic Elderly Patients With Atrial Fibrillation Clinical Trial (PACIFIC) - Pilot Study

Conditions
-----------------
Atrial Fibrillation, Heart Failure

Intervention / Treatment
-----------------
* Drug: FDA approved rate and rhythm control drugs
* Device: AV Node ablation and device implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 65 years Paroxysmal, persistent, or permanent atrial fibrillation Index event of atrial fibrillation is documented on electrocardiogram or rhythm strip. Atrial fibrillation must be the qualifying event. Atrial flutter can have been present in the past, but it must not be considered the index arrhythmia. Paroxysmal atrial fibrillation episodes must be recurrent (two or more episodes in the past 6 months). At least one of the paroxysmal episodes must be sustained, defined as lasting greater than 1 hour documented by a Holter monitor or by history in conjunction with an ECG or a rhythm strip. At least one attempt of unsuccessful drug therapy, either for rate, for rhythm, or for rate-and-rhythm control. Symptoms related to atrial fibrillation within the last 6 months Eligible for long-term treatment with both treatment strategies Must provide informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and be willing to comply with follow-up requirements. Exclusion Criteria: Reversible causes of atrial fibrillation On heart transplant list Familial cardiac conditions with increased risk of sudden death Asymptomatic Medical condition limiting expected survival to be less than one year Contraindications to anticoagulation Pre-existing implanted pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device. Pre-existing indication for permanent pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device More than one attempt of drug therapy for rate, for rhythm, or for rate-and-rhythm control Planned major surgery within the next six months, including thoracic surgery Disability that would preclude collection of study data or have co-morbidity that would contraindicate device implantation Participated in another clinical trial within the previous 30 days using a therapeutic modality which could have potential residual effects that might confound the results of this pilot study Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Therapy<br>FDA approved rate and rhythm control drugs | Drug: FDA approved rate and rhythm control drugs<br>* 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<br>* Other names: Pacerone;|
| Active Comparator: Atrioventricular Node (AVN) Ablation / Pacing<br>AV Node ablation and device implant | Device: AV Node ablation and device implant<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Hospitalization Within Six Months of Enrollment | Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment. | Six months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Heart Failure, AV Node ablation, Cardiac pacemaker, Antiarrhythmic drug