Phase 3
N=523
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Postoperative Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02132767 ↗Enrolled (actual)
523
Serious AEs
27.5%
Results posted
Jan 2017
Primary outcome: Primary: Total Number of Days in Hospital — 5.1; 5.0 days — p=0.76
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amiodarone (Drug); DC-cardioversion (Procedure); Rate Control (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Sep 2015
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 Heart Rhythm Comparison |
220; 231 | 0.03 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) |
— | — |
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.
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). 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.