Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Recruitment status was Recruiting
|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|
- 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.
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558128
|Contact: Gregory Kerr, M.D.||firstname.lastname@example.org|
|Contact: Michele Steinkamp, RNemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Michele Steinkamp, RN 212-746-2953 firstname.lastname@example.org|
|Principal Investigator: Gregory Kerr, MD|
|Sub-Investigator: Khaled Dajani, MD|
|Principal Investigator:||Gregory Kerr, MD||Weill Medical College of Cornell University|