Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
- Conditions
- Postoperative Atrial Fibrillation
- Interventions
- Registration Number
- NCT02132767
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 523
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rate control Rate Control Rate Control in post-operative AF Beta-blocker and/or Calcium channel blockers and/or Digoxin Dose, frequency and duration determined by medical professional as medically needed Rhythm control DC-cardioversion Rhythm Control in post-operative AF Amiodarone and/or DC-cardioversion 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 DC-Cardioversion - frequency and duration determined by medical professional as medically needed Rhythm control Amiodarone Rhythm Control in post-operative AF Amiodarone and/or DC-cardioversion 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 DC-Cardioversion - frequency and duration determined by medical professional as medically needed
- Primary Outcome Measures
Name Time Method Total Number of Days in Hospital Within 60 days of randomization The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
- Secondary Outcome Measures
Name Time Method Cost (Hospital) Within 60 days of randomization Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups
Heart Rhythm Comparison 60 days after randomization Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization
AF- or Treatment-related Events Within 60 days of randomization Time to Conversion to Sustained, Stable Non-AF Rhythm Up to index hospital discharge or 7 days post surgery, whichever came first Length of Stay (Index Hospitalization) Within 60 days post surgery Overall length of stay for the index hospitalization
Length of Stay (Rehospitalization, Including ED Visits) Within 60 days of randomization Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits
Outpatient Interventions Within 60 days of randomization Compare frequency of outpatient visits between groups for any cause and AF-related causes
Trial Locations
- Locations (23)
Montefiore Einstein Heart Center
🇺🇸Bronx, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Virginia Health Systems
🇺🇸Charlottesville, Virginia, United States
Baylor Research Institute
🇺🇸Plano, Texas, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Hôpital du Sacré-Cœur de Montréal
🇨🇦Montreal, Quebec, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
🇨🇦Quebec, Canada
Centre Hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
NIH Heart Center at Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Michigan Health Services
🇺🇸Ann Arbor, Michigan, United States