Back to resultsCombined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Primary Purpose
Cardiac Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amiodarone
Cardioversion
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects who underwent CABG and/or cardiac valve surgery involving cardiopulmonary bypass and develop postoperative atrial fibrillation within 7 days after surgery
Exclusion Criteria:
- Subjects who had any form of atrial fibrillation prior to surgery
- Subjects who were on antiarrhythmic medications preoperatively, including but not limited to procainamide and amiodarone
Sites / Locations
- Weill Cornell Medical College
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Amiodarone with cardioversion
Arm Description
If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Outcomes
Primary Outcome Measures
Subject Rhythm
Measuring change from baseline cardiac rhythm.
Secondary Outcome Measures
Full Information
NCT ID
NCT01558128
First Posted
March 7, 2012
Last Updated
April 21, 2017
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT01558128
Brief Title
Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Official Title
Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Recruitment
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop postoperative atrial fibrillation
Detailed Description
New-onset atrial fibrillation (AF) after cardiac surgery is a well-recognized phenomenon with significant outcome implications. Incidence after coronary artery bypass grafting (CABG) is estimated at 26-33%, while those undergoing valvular surgery bear a greater burden at 33-49%. Clinical and socioeconomic complications resulting from postoperative atrial fibrillation include an increased risk of death (10%), congestive heart failure (4%), prolonged hospital stays, and increased rate of discharge to care facilities over those who remain in sinus rhythm, (7%). Although a body of evidence exists for electrical or pharmacological cardioversion to sinus rhythm postoperatively, there is a marked paucity in the literature regarding efficacy and outcomes combining the two. More specifically, we seek to evaluate the efficacy of DC cardioversion when combined with amiodarone. Improved outcomes with multimodal cardioversion may decrease the postoperative clinical burden of atrial fibrillation on cardiac surgery patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amiodarone with cardioversion
Arm Type
Other
Arm Description
If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Other Intervention Name(s)
Cordarone
Intervention Description
Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
Intervention Type
Procedure
Intervention Name(s)
Cardioversion
Intervention Description
Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.
Primary Outcome Measure Information:
Title
Subject Rhythm
Description
Measuring change from baseline cardiac rhythm.
Time Frame
Participants will be followed for the duration of their hospital stay post surgery with an expected average of 7 to 10 days and again at surgical follow up appointment up to 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who underwent CABG and/or cardiac valve surgery involving cardiopulmonary bypass and develop postoperative atrial fibrillation within 7 days after surgery
Exclusion Criteria:
Subjects who had any form of atrial fibrillation prior to surgery
Subjects who were on antiarrhythmic medications preoperatively, including but not limited to procainamide and amiodarone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Kerr, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD
Learn more about this trial
Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
We'll reach out to this number within 24 hrs