Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
2 other identifiers
interventional
523
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2014
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 5, 2014
CompletedFirst Posted
Study publicly available on registry
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
January 18, 2017
CompletedMarch 15, 2019
February 1, 2019
1.3 years
May 5, 2014
September 30, 2016
February 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Number of Days in Hospital
The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.
Within 60 days of randomization
Secondary Outcomes (9)
Time to Conversion to Sustained, Stable Non-AF Rhythm
Up to index hospital discharge or 7 days post surgery, whichever came first
Heart Rhythm Comparison
Hospital discharge
Heart Rhythm Comparison
30 days after randomization
Heart Rhythm Comparison
60 days after randomization
Length of Stay (Index Hospitalization)
Within 60 days post surgery
- +4 more secondary outcomes
Study Arms (2)
Rhythm control
ACTIVE COMPARATORRhythm 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
Rate control
ACTIVE COMPARATORRate 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
Interventions
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
Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed
Eligibility Criteria
You may qualify if:
- 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
- AF that persists for \> 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Southern California
Los Angeles, California, 90033, United States
Emory University
Atlanta, Georgia, 30308, United States
University of Maryland
Baltimore, Maryland, 21201, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, 20814, United States
University of Michigan Health Services
Ann Arbor, Michigan, 48109, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Einstein Heart Center
The Bronx, New York, 10467, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Baylor Research Institute
Plano, Texas, 75093, United States
University of Virginia Health Systems
Charlottesville, Virginia, 22908, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Toronto General Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2W 1T8, Canada
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5, Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec, Quebec, G1V 4G5, Canada
Related Publications (2)
Afifi A. CTS trials network: Rate control vs rhythm control for atrial fibrillation after cardiac surgery - Do bitter pills have blessed effects? Glob Cardiol Sci Pract. 2016 Jun 30;2016(2):e201615. doi: 10.21542/gcsp.2016.15.
PMID: 29043263DERIVEDGillinov AM, Bagiella E, Moskowitz AJ, Raiten JM, Groh MA, Bowdish ME, Ailawadi G, Kirkwood KA, Perrault LP, Parides MK, Smith RL 2nd, Kern JA, Dussault G, Hackmann AE, Jeffries NO, Miller MA, Taddei-Peters WC, Rose EA, Weisel RD, Williams DL, Mangusan RF, Argenziano M, Moquete EG, O'Sullivan KL, Pellerin M, Shah KJ, Gammie JS, Mayer ML, Voisine P, Gelijns AC, O'Gara PT, Mack MJ; CTSN. Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery. N Engl J Med. 2016 May 19;374(20):1911-21. doi: 10.1056/NEJMoa1602002. Epub 2016 Apr 4.
PMID: 27043047DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Annetine C. Gelijns, PhD
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- STUDY CHAIR
Richard Wiesel, MD
Cardiothoracic Surgical Trials Network
- STUDY CHAIR
Patrick T O'Gara, MD
Cardiothoracic Surgical Trials Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair, Health Evidence and Policy
Study Record Dates
First Submitted
May 5, 2014
First Posted
May 7, 2014
Study Start
May 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 15, 2019
Results First Posted
January 18, 2017
Record last verified: 2019-02