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

Not Applicable

Terminated

• Conditions: Cardiac Disease
• Interventions: Drug: Amiodarone; Procedure: Cardioversion

• Registration Number: NCT01558128
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-20
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2017-02-16
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Results First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amiodarone with cardioversion	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.
Amiodarone with cardioversion	Amiodarone	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.

Primary Outcome Measures

Name	Time	Method
Subject Rhythm	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.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States