27
Participants
Start Date
December 31, 2007
Primary Completion Date
July 31, 2011
Study Completion Date
July 31, 2011
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"
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"
Chattanooga Heart Institute, Chattanooga
The Heart Group, Evansville
Mayo Clinic, Rochester
Mayo Clinic Arizona, Scottsdale
Oregon Health and Science University, Portland
University of Calgary and Calgary Health Region, Calgary
Lead Sponsor
Collaborators (1)
Medtronic
INDUSTRY
Mayo Clinic
OTHER