AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
Condition: Atrial Fibrillation; Heart Failure
MeSH terms: Heart Failure; Atrial Fibrillation
Intervention: FDA approved rate and rhythm control drugs; AV Node ablation and device implant
Intervention description: 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; 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
Intervention MeSH terms: Metoprolol; Amiodarone; Verapamil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Heart Failure; AV Node ablation; Cardiac pacemaker; Antiarrhythmic drug

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).
    

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