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Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

Primary Purpose

Postoperative Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Amiodarone
DC-cardioversion
Rate Control
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Atrial Fibrillation focused on measuring Heart surgery, Cardiac surgery, Coronary artery bypass, Mitral valve surgery, Aortic valve surgery, Atrial fibrillation, Atrial flutter, Cardiac arrhythmia, Valve surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California
  • Emory University
  • University of Maryland
  • NIH Heart Center at Suburban Hospital
  • University of Michigan Health Services
  • Montefiore Einstein Heart Center
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center
  • Mission Hospital
  • Duke University
  • Cleveland Clinic Foundation
  • The Ohio State University Medical Center
  • University of Pennsylvania
  • Baylor College of Medicine
  • Baylor Research Institute
  • University of Virginia Health Systems
  • University of Wisconsin
  • University of Alberta Hospital
  • Toronto General Hospital
  • Centre Hospitalier de l'Université de Montréal
  • Hôpital du Sacré-Cœur de Montréal
  • Montreal Heart Institute
  • Institut Universitaire de Cardiologie de Quebec (Hopital Laval)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rhythm control

Rate control

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Conversion to Sustained, Stable Non-AF Rhythm
Heart Rhythm Comparison
Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge
Heart Rhythm Comparison
Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization
Heart Rhythm Comparison
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)
Overall length of stay for the index hospitalization
Length of Stay (Rehospitalization, Including ED Visits)
Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits
Outpatient Interventions
Compare frequency of outpatient visits between groups for any cause and AF-related causes
AF- or Treatment-related Events
Cost (Hospital)
Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups

Full Information

First Posted
May 5, 2014
Last Updated
February 28, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02132767
Brief Title
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Official Title
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atrial Fibrillation
Keywords
Heart surgery, Cardiac surgery, Coronary artery bypass, Mitral valve surgery, Aortic valve surgery, Atrial fibrillation, Atrial flutter, Cardiac arrhythmia, Valve surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
523 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Wiesel, MD
Organizational Affiliation
Cardiothoracic Surgical Trials Network
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick T O'Gara, MD
Organizational Affiliation
Cardiothoracic Surgical Trials Network
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
NIH Heart Center at Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
University of Michigan Health Services
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Montefiore Einstein Heart Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia Health Systems
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Hôpital du Sacré-Cœur de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29043263
Citation
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.
Results Reference
derived
PubMed Identifier
27043047
Citation
Gillinov 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.
Results Reference
derived
Links:
URL
http://www.ctsurgerynet.org/
Description
Cardiothoracic Surgical Trials Network Website

Learn more about this trial

Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation

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