Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
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ClinicalTrials.gov Identifier: NCT02132767 |
Recruitment Status :
Completed
First Posted : May 7, 2014
Results First Posted : January 18, 2017
Last Update Posted : March 15, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Atrial Fibrillation | Drug: Amiodarone Procedure: DC-cardioversion Drug: Rate Control | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 523 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Rhythm control
Rhythm Control in post-operative AF Amiodarone and/or DC-cardioversion Amiodarone Initial Dose
DC-Cardioversion - frequency and duration determined by medical professional as medically needed |
Drug: Amiodarone
Amiodarone Initial Dose
Other Name: Cordarone Procedure: DC-cardioversion DC-Cardioversion - frequency and duration determined by medical professional as medically needed
Other Name: Direct Current Cardioversion |
Active Comparator: 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 |
Drug: Rate Control
Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed
Other Names:
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- Total Number of Days in Hospital [ Time Frame: 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.
- Time to Conversion to Sustained, Stable Non-AF Rhythm [ Time Frame: Up to index hospital discharge or 7 days post surgery, whichever came first ]
- Heart Rhythm Comparison [ Time Frame: Hospital discharge ]Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge
- Heart Rhythm Comparison [ Time Frame: 30 days after randomization ]Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization
- Heart Rhythm Comparison [ Time Frame: 60 days after randomization ]Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization
- Length of Stay (Index Hospitalization) [ Time Frame: Within 60 days post surgery ]Overall length of stay for the index hospitalization
- Length of Stay (Rehospitalization, Including ED Visits) [ Time Frame: Within 60 days of randomization ]Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits
- Outpatient Interventions [ Time Frame: Within 60 days of randomization ]Compare frequency of outpatient visits between groups for any cause and AF-related causes
- AF- or Treatment-related Events [ Time Frame: Within 60 days of randomization ]
- Cost (Hospital) [ Time Frame: Within 60 days of randomization ]Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132767

Study Chair: | Richard Wiesel, MD | Cardiothoracic Surgical Trials Network | |
Study Chair: | Patrick T O'Gara, MD | Cardiothoracic Surgical Trials Network |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Annetine Gelijns, Professor and Chair, Health Evidence and Policy, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT02132767 |
Other Study ID Numbers: |
GCO 08-1078-00007 5U01HL088942-08 ( U.S. NIH Grant/Contract ) |
First Posted: | May 7, 2014 Key Record Dates |
Results First Posted: | January 18, 2017 |
Last Update Posted: | March 15, 2019 |
Last Verified: | February 2019 |
Heart surgery Cardiac surgery Coronary artery bypass Mitral valve surgery Aortic valve surgery |
Atrial fibrillation Atrial flutter Cardiac arrhythmia Valve surgery |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Digoxin Amiodarone Calcium Channel Blockers Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiotonic Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Vasodilator Agents Potassium Channel Blockers Membrane Transport Modulators Sodium Channel Blockers Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 CYP3A Inhibitors |