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Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01558128
Recruitment Status : Terminated (Insufficient Recruitment)
First Posted : March 20, 2012
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop postoperative atrial fibrillation

Condition or disease Intervention/treatment
Cardiac Disease Drug: Amiodarone Procedure: Cardioversion

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Study Start Date : March 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Amiodarone with cardioversion
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.
Drug: Amiodarone
Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
Other Name: Cordarone
Procedure: Cardioversion
Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.

Primary Outcome Measures :
  1. Subject 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. ]
    Measuring change from baseline cardiac rhythm.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558128

United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Gregory Kerr, MD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01558128     History of Changes
Other Study ID Numbers: 1105011705
First Posted: March 20, 2012    Key Record Dates
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors