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.
Brief Title
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Postoperative Atrial Fibrillation
Eligibility Criteria
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
* 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
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Heart surgery
Cardiac surgery
Coronary artery bypass
Mitral valve surgery
Aortic valve surgery
Atrial fibrillation
Atrial flutter
Cardiac arrhythmia
Valve surgery
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02132767
Org Class
Other
Org Full Name
Icahn School of Medicine at Mount Sinai
Org Study Id
GCO 08-1078-00007
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Primary Outcomes
Outcome Description
The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
Outcome Measure
Total Number of Days in Hospital
Outcome Time Frame
Within 60 days of randomization
Secondary Ids
Secondary Id
5U01HL088942-08
Secondary Outcomes
Outcome Time Frame
Up to index hospital discharge or 7 days post surgery, whichever came first
Outcome Measure
Time to Conversion to Sustained, Stable Non-AF Rhythm
Outcome Description
Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge
Outcome Time Frame
Hospital discharge
Outcome Measure
Heart Rhythm Comparison
Outcome Description
Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization
Outcome Time Frame
30 days after randomization
Outcome Measure
Heart Rhythm Comparison
Outcome Description
Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization
Outcome Time Frame
60 days after randomization
Outcome Measure
Heart Rhythm Comparison
Outcome Description
Overall length of stay for the index hospitalization
Outcome Time Frame
Within 60 days post surgery
Outcome Measure
Length of Stay (Index Hospitalization)
Outcome Description
Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits
Outcome Time Frame
Within 60 days of randomization
Outcome Measure
Length of Stay (Rehospitalization, Including ED Visits)
Outcome Description
Compare frequency of outpatient visits between groups for any cause and AF-related causes
Outcome Time Frame
Within 60 days of randomization
Outcome Measure
Outpatient Interventions
Outcome Time Frame
Within 60 days of randomization
Outcome Measure
AF- or Treatment-related Events
Outcome Description
Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups
Outcome Time Frame
Within 60 days of randomization
Outcome Measure
Cost (Hospital)
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Robert Michler
Investigator Email
RMICHLER@MONTEFIORE.ORG
Investigator Phone
rmichler