Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Mount Sinai Health System

Status and phase: Completed; Phase 3

Conditions: Postoperative Atrial Fibrillation

Treatments: Drug: Amiodarone; Procedure: DC-cardioversion; Drug: Rate Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02132767

5U01HL088942-08 (U.S. NIH Grant/Contract)

GCO 08-1078-00007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 523 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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523 participants in 2 patient groups

Rhythm control

Active Comparator group

Description:

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

Treatment:

Procedure: DC-cardioversion

Drug: Amiodarone

Rate control

Active Comparator group

Description:

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

Treatment:

Drug: Rate Control