Phase 3
Completed N=523
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Postoperative Atrial Fibrillation
Source: ClinicalTrials.gov NCT02132767 ↗
Enrolled (actual)
523
Serious AEs
27.5%
Results posted
Jan 2017
Primary outcomePrimary: Total Number of Days in Hospital — 5.1; 5.0 days — p=0.76
◆ Published Evidence
Highly cited
398citations · ~40 / year
Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.
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.
Linked Publications (2)
-
Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery.
-
CTS trials network: Rate control vs rhythm control for atrial fibrillation after cardiac surgery - Do bitter pills have blessed effects?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Days in Hospital |
5.1; 5.0 | 0.76 |
| SECONDARY Time to Conversion to Sustained, Stable Non-AF Rhythm |
1.85; 0.95 | 0.003 sig |
| SECONDARY Heart Rhythm Comparison |
220; 231 | 0.03 sig |
| SECONDARY Length of Stay (Index Hospitalization) |
4.3; 4.3 | 0.88 |
| SECONDARY Length of Stay (Rehospitalization, Including ED Visits) |
2.2; 2.1 | 0.82 |
| SECONDARY Outpatient Interventions |
5; 4 | 0.73 |
| SECONDARY AF- or Treatment-related Events |
— | — |
| SECONDARY Cost (Hospital) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02132767) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.