NCT01742039

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

2.9 years

First QC Date

November 14, 2012

Last Update Submit

October 12, 2023

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • length of stay

    participants will be followed for the duration of hospital stay, an expected average of 5 days

Study Arms (4)

b-blocker

amiodarone

atrial pacing

amiodarone plus atrial pacing

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult patients undergoing open heart surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2012

First Posted

December 5, 2012

Study Start

July 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

US(2)