Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:May 2014
End Date:May 2016
Contact:Elise Barrow, MPH
Email:elise.barrow@mountsinai.org
Phone:212-659-6862

Use our guide to learn which trials are right for you!

The purpose of this study is to compare the therapeutic strategies of rate control versus
rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial
fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization
after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days
in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.

The purpose of the research is to compare two strategies for treating atrial fibrillation or
atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most
common complication after cardiac surgery. AF is when the upper chambers of the heart
(atria) experience disorganized electrical activity which causes the heart beat to be
irregular. The two treatment strategies to be used in this study are called rhythm control
and rate control. The rhythm control strategy will attempt to bring the heart beat back to
a regular rhythm using treatments known and approved to control heart rhythm. The rate
control strategy will attempt to bring the heart rate to less than 100 beats per minute at
rest using medications known and recommended to control heart rate. Both strategies are
commonly used to treat AF. All of the medications that will be used in this study are the
standard of care for use in patients experiencing AF. This research seeks to determine
whether rhythm control is better than rate control in patients with AF after cardiac
surgery.

Enrollment Inclusion Criteria:

- Age > 18 years

- Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or
valve repair or replacement (excluding mechanical valves), including re-operations

- Hemodynamically stable

Randomization Inclusion Criteria

- AF that persists for > 60 minutes or recurrent (more than one) episodes of AF up to 7
days after surgery during the index hospitalization.

Exclusion Criteria:

- LVAD insertion or heart transplantation

- Maze procedure

- TAVR

- History of or planned mechanical valve replacement

- Correction of complex congenital cardiac defect (excluding bicuspid aortic valve,
atrial septal defect or PFO)

- History of AF or AFL

- History of AF or AFL ablation

- Contraindications to warfarin or amiodarone

- Need for long-term anticoagulation

- Concurrent participation in an interventional (drug or device) trial
We found this trial at
17
sites
201 Dowman Dr
Atlanta, Georgia 30308
404.727.6123
Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Bronx, New York 10467
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
?
mi
from
New York, NY
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plano, Texas 75093
?
mi
from
Plano, TX
Click here to add this to my saved trials