Postoperative Atrial FibrillationNCT01742039
Prevention of Postoperative Atrial Fibrillation
An observational study of Postoperative Atrial Fibrillation, run by George Washington University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Atrial Fibrillation
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult patients undergoing open heart surgery
Who may be able to join
- age > or = to 18 years
- sinus rhythm
- undergoing either coronary artery bypass graft surgery (CABG), valvular heart surgery or a combined procedure
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
George Washington University Hospital
Washington D.C., District of Columbia, 20037
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
- Conditions
- Postoperative Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| b-blocker | Not described | |
| amiodarone | Not described | |
| atrial pacing | Not described | |
| amiodarone plus atrial pacing | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: postoperative day 0-day of discharge (an average of 5 days)
Secondary outcomes (1)
length of stay
The secondary endpoint was the length of hospital stay after surgery.
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJul 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742039
- Sponsor's protocol ID
- AF01
- Status last verified
- Oct 2023
- First submitted
- 14 Nov 2012
- Last updated
- 13 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Therapeutic Strategy to Reduce the Incidence of Postoperative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01742039
- Acronym / sponsor ID
- AF01
- Conditions
- Postoperative Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| b-blocker | – | – |
| amiodarone | – | – |
| atrial pacing | – | – |
| amiodarone plus atrial pacing | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients undergoing open heart surgery
Key inclusion criteria (3 listed)
- age > or = to 18 years
- sinus rhythm
- undergoing either coronary artery bypass graft surgery (CABG), valvular heart surgery or a combined procedure
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of atrial fibrillation
Time frame: postoperative day 0-day of discharge (an average of 5 days)
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.
occurrence of atrial fibrillation
Time frame: postoperative day 0-day of discharge (an average of 5 days)
The primary endpoint of this study was the occurrence of atrial fibrillation lasting longer than five minutes
1 secondary outcome
length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Atrial Fibrillation, run by George Washington University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of atrial fibrillation (time frame: postoperative day 0-day of discharge (an average of 5 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.