Prevention of Postoperative Atrial Fibrillation

A New Therapeutic Strategy to Reduce the Incidence of Postoperative Atrial Fibrillation

The primary aim of this study is to determine the safest and most effective therapeutic strategy to decrease the incidence of postoperative atrial fibrillation following cardiac surgery in an era with shorter ICU and hospital length of stay. A secondary goal is to evaluate the length of hospital stay associated with each treatment strategy.

Study Overview

• Status: Completed
• Conditions: Postoperative Atrial Fibrillation

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

adult patients undergoing open heart surgery

Description

Inclusion Criteria:

• age > or = to 18 years
• sinus rhythm
• undergoing either coronary artery bypass graft surgery (CABG), valvular heart surgery or a combined procedure

Exclusion Criteria:

• received a class-I or class-III antiarrhythmic agent in the past six months
• had second or third degree heart block
• had a resting heart rate of less than 50 beats per minute
• had a systolic blood pressure less than 100 mmHg
• had severe asthma or severe chronic obstructive pulmonary disease
• had uncontrolled heart failure
• had a serum aspartate aminotransferase or alanine aminotransferase concentration greater than four times the upper limit of normal

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
b-blocker
amiodarone
atrial pacing
amiodarone plus atrial pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of atrial fibrillation	The primary endpoint of this study was also the occurrence of atrial fibrillation for any length of time requiring treatment as a result of symptoms or hemodynamic compromise.	postoperative day 0-day of discharge (an average of 5 days)
occurrence of atrial fibrillation	The primary endpoint of this study was the occurrence of atrial fibrillation lasting longer than five minutes	postoperative day 0-day of discharge (an average of 5 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	The secondary endpoint was the length of hospital stay after surgery.	participants will be followed for the duration of hospital stay, an expected average of 5 days

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimated): December 5, 2012

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No