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Clinical Trials/NCT01558128
NCT01558128
Terminated
Not Applicable

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

Weill Medical College of Cornell University1 site in 1 country1 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Amiodarone
Conditions
Cardiac Disease
Sponsor
Weill Medical College of Cornell University
Enrollment
1
Locations
1
Primary Endpoint
Subject Rhythm
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
March 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Amiodarone

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.

Intervention: Cardioversion

Outcomes

Primary Outcomes

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.

Study Sites (1)

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