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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01558128
Other study ID # 1105011705
Secondary ID
Status Recruiting
Phase N/A
First received March 7, 2012
Last updated March 16, 2012
Start date March 2012

Study information

Verified date March 2012
Source Weill Medical College of Cornell University
Contact Gregory Kerr, M.D.
Phone 212.746.2953
Email gekerr@med.cornell.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Weill Cornell Medical College New York New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject rhythm Measuring change from baseline cardiac 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. No
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