Prevention of Postoperative Atrial Fibrillation

Postoperative Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742039
• Other study ID #: AF01
• Status: Completed
• Start date: July 2008
• Est. completion date: June 2011

Study information

• Verified date: October 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Postoperative Atrial Fibrillation

Locations

Country	Name	City	State
United States	George Washington University	Washington	District of Columbia
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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