Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Description
Brief Summary
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.
Detailed Description
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.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion 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.
- 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
Sites
-
California
- University of Southern California, Los Angeles, California, 90033
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Texas
- Baylor Research Institute, Plano, Texas, 75093
- Baylor College of Medicine, Houston, Texas, 77030
-
Wisconsin
- University of Wisconsin, Madison, Wisconsin, 53792
-
Georgia
- Emory University, Atlanta, Georgia, 30308
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