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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01742039
Other study ID # AF01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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