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

PHASE3TerminatedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Atrial FibrillationHeart Failure
Interventions
DRUG

FDA approved rate and rhythm control drugs

"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"

DEVICE

AV Node ablation and device implant

"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"

Trial Locations (6)

37404

Chattanooga Heart Institute, Chattanooga

47710

The Heart Group, Evansville

55905

Mayo Clinic, Rochester

85259

Mayo Clinic Arizona, Scottsdale

97239

Oregon Health and Science University, Portland

T2N-4N1

University of Calgary and Calgary Health Region, Calgary

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

Mayo Clinic

OTHER