Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2019 |
Start Date: | May 2014 |
End Date: | September 2015 |
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.
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.
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
18
sites
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Southern California The University of Southern California is one of the world’s leading...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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