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

This study is currently recruiting participants.
Verified March 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01558128
First received: March 7, 2012
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention
Cardiac Surgery
 Drug: Amiodarone
Procedure: Cardioversion

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Measuring change from baseline cardiac rhythm.


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Amiodarone
    Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
    Procedure: Cardioversion
    Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.
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.

This will be a prospective observational study, posing minimal risk to subjects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558128

Contacts
Contact: Gregory Kerr, M.D. 212.746.2953 gekerr@med.cornell.edu
Contact: Michele Steinkamp, RN 2127462953 mls9004@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Michele Steinkamp, RN     212-746-2953     mls9004@med.cornell.edu    
Principal Investigator: Gregory Kerr, MD            
Sub-Investigator: Khaled Dajani, MD            
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Gregory Kerr, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01558128     History of Changes
Other Study ID Numbers: 1105011705
Study First Received: March 7, 2012
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013