Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

PHASE3CompletedINTERVENTIONAL
Enrollment

523

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Postoperative Atrial Fibrillation
Interventions
DRUG

Amiodarone

"Amiodarone Initial Dose~* Oral: 400 mg po TID for 3 days is recommended~* For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose~* Oral: at least 200 mg/day to be continued until 60 days after randomization~* If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started"

PROCEDURE

DC-cardioversion

DC-Cardioversion - frequency and duration determined by medical professional as medically needed

DRUG

Rate Control

Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed

Trial Locations (23)

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center, New York

10467

Montefiore Einstein Heart Center, The Bronx

19104

University of Pennsylvania, Philadelphia

20814

NIH Heart Center at Suburban Hospital, Bethesda

21201

University of Maryland, Baltimore

22908

University of Virginia Health Systems, Charlottesville

27710

Duke University, Durham

28801

Mission Hospital, Asheville

30308

Emory University, Atlanta

43210

The Ohio State University Medical Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

48109

University of Michigan Health Services, Ann Arbor

53792

University of Wisconsin, Madison

75093

Baylor Research Institute, Plano

77030

Baylor College of Medicine, Houston

90033

University of Southern California, Los Angeles

T6G 2B7

University of Alberta Hospital, Edmonton

M5B 1W8

Toronto General Hospital, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

H2W 1T8

Centre Hospitalier de l'Université de Montréal, Montreal

H4J 1C5

Hôpital du Sacré-Cœur de Montréal, Montreal

G1V 4G5

Institut Universitaire de Cardiologie de Quebec (Hopital Laval), Québec

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT02132767 - Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation | Biotech Hunter | Biotech Hunter