Atrial FibrillationMonitor-AFNCT01395836
Management of New-Onset Postoperative Atrial Fibrillation
An observational study of Atrial Fibrillation and Coronary Artery Disease, run by Emory University at 1 site in United States.
Trial summary
One common occurrence following open heart surgery is an irregular rhythm from the top chambers of the heart known as atrial fibrillation (afib or AF). It is known that about 30% of patients who have had bypass surgery without having a heart valve replaced at the same time will develop AF. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease, Post Operative Arrythmia
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing isolated CABG at Emory University Hospital Midtown will be followed post-operatively and screened for inclusion to the trial.
Who may be able to join
- Subject is able and willing to sign and date the Patient Consent Form.
- Subject is 18 years of age or older.
- Subject is expected to remain available for at least 12 months of follow- up visits.
- Subject is willing to comply with the protocol, including follow-up visits, medication compliance, carelink transmissions, and randomization assignment.
- Subject has a CHADS2 score of ≥ 1.
- Subject is hospitalized post isolated CABG or is within 72 hours post hospital discharge from a CABG procedure.
- Subject has no previous history of AF and has developed new-onset postoperative atrial fibrillation according to the established STS definition, which defines it as the occurrence of POAF or atrial flutter requiring treatment (i.e. beta-blockers, calcium-channel blockers, amiodarone, anticoagulation, or cardioversion).
Who cannot join
- Subject has a medically documented history of paroxysmal or persistent atrial fibrillation or atrial flutter.
- Subject is pregnant.
- Subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician.
- Subject has previously or is scheduled to undergo valve repair or valve replacement during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital Midtown
Atlanta, Georgia, 30308
About this study
Official title: Management of New-Onset Postoperative Atrial Fibrillation Utilizing Insertable Cardiac Monitor Technology to Observe Recurrence of AF
One common occurrence following open heart surgery is an irregular rhythm from the top chambers of the heart known as atrial fibrillation (afib or AF). It is known that about 30% of patients who have had bypass surgery without having a heart valve replaced at the same time will develop AF. It is felt that this occurrence leads to factors that will affect a subjects health for the rest of their life. In studying this the investigators will see if post operative afib is an indicator of a person having afib and is not a condition that may only last during the post op recovery period as many physicians feel.The problem in question is, is post operative afib only transient or is it an indicator for more long term episodes of afib that may lead to other health concerns like stroke. Fifty subjects will be asked to participate. There will be to groups of 25 subjects. All subjects will have a device implanted under the skin that will be able to detect all types of heart rhythms. One group will get standard treatment and the physicians will be blinded to the recordings. The other group will be treated by the recording and the information about the amount of time in afib. The purpose of the study is to determine what the true occurrence of afib is for the first year after open heart surgery and to see if knowing this will alter the clinical management of this group of subjects.Currently most subjects are treated without knowing this information and based on that the arrhythmia will no longer happen after the heart is healed or recovered from the surgery. Most medications for controlling the heart rate and rhythm are stopped around 3 months. There is also a tendency to not to use blood thinning medications for the prevention of stroke after this time period. Stroke is one of the major complications from afib. Not all subjects are aware of the irregular heart beats so you can not depend on them to accurately know. They might feel episodes of very fast beating episodes or may become weak and fatigued. Weakness and fatigue are also normal during the first parts of recover from bypass surgery. By documenting the true episodes of afib the investigators can better understand if postoperative afib might need to be treated as a life long issue rather than a transient post operative issue. This treatment might change clinical management and decrease mortality.
- Keywords
- Coronary Artery Bypass Grafting, Cardiology, Cardiac Electrophysiology, Cardiac Surgery
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
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 |
|---|---|---|
| Treatment | The "treatment" group will be medically managed based on data obtained from monthly transmissions of the implanted Cardiac Monitor. | |
| Control Group | The "control" group will be managed in the usual standard of care with physicians blinded to their ICM data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of AF at any post-operative points in time.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Emory 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Mikhael El Chami, Emory University
- Investigators
- Mikhael F El Chami, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395836
- Sponsor's protocol ID
- IRB00047554a
- Other IDs
- EPEUHM
- Acronym
- Monitor-AF
- Status last verified
- Nov 2016
- First submitted
- 14 Jul 2011
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Chami MF, Merchant FM, Smith P, Levy M, Nelms AG, Merlino J, Puskas J, Leon AR. Management of New-Onset Postoperative Atrial Fibrillation Utilizing Insertable Cardiac Monitor Technology to Observe Recurrence of AF (MONITOR-AF). Pacing Clin Electrophysiol. 2016 Oct;39(10):1083-1089. doi: 10.1111/pace.12949. Epub 2016 Sep 22.
PubMed 27570120
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of New-Onset Postoperative Atrial Fibrillation Utilizing Insertable Cardiac Monitor Technology to Observe Recurrence of AF
- ClinicalTrials.gov ID
- NCT01395836
- Acronym / sponsor ID
- Monitor-AF / IRB00047554a
- Keywords
- Coronary Artery Bypass Grafting, Cardiology, Cardiac Electrophysiology, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Jul 2011 (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.
One common occurrence following open heart surgery is an irregular rhythm from the top chambers of the heart known as atrial fibrillation (afib or AF). It is known that about 30% of patients who have had bypass surgery without having a heart valve replaced at the same time will develop AF. It is felt that this occurrence leads to factors that will affect a subjects health for the rest of their life. In studying this the investigators will see if post operative afib is an indicator of a person having afib and is not a condition that may only last during the post op recovery period as many physicians feel.The problem in question is, is post operative afib only transient or is it an indicator for more long term episodes of afib that may lead to other health concerns like stroke. Fifty subjects will be asked to participate. There will be to groups of 25 subjects. All subjects will have a device implanted under the skin that will be able to detect all types of heart rhythms. One group will get standard treatment and the physicians will be blinded to the recordings. The other group will be treated by the recording and the information about the amount of time in afib. The purpose of the study is to determine what the true occurrence of afib is for the first year after open heart surgery and to see if knowing this will alter the clinical management of this group of subjects.Currently most subjects are treated without knowing this information and based on that the arrhythmia will no longer happen after the heart is healed or recovered from the surgery. Most medications for controlling the heart rate and rhythm are stopped around 3 months. There is also a tendency to not to use blood thinning medications for the prevention of stroke after this time period. Stroke is one of the major complications from afib. Not all subjects are aware of the irregular heart beats so you can not depend on them to accurately know. They might feel episodes of very fast beating episodes or may become weak and fatigued. Weakness and fatigue are also normal during the first parts of recover from bypass surgery. By documenting the true episodes of afib the investigators can better understand if postoperative afib might need to be treated as a life long issue rather than a transient post operative issue. This treatment might change clinical management and decrease mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | –The "treatment" group will be medically managed based on data obtained from monthly transmissions of the implanted Cardiac Monitor. |
| Control Group | – | –The "control" group will be managed in the usual standard of care with physicians blinded to their ICM data. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing isolated CABG at Emory University Hospital Midtown will be followed post-operatively and screened for inclusion to the trial.
Key inclusion criteria (7 listed)
- Subject is able and willing to sign and date the Patient Consent Form.
- Subject is 18 years of age or older.
- Subject is expected to remain available for at least 12 months of follow- up visits.
- Subject is willing to comply with the protocol, including follow-up visits, medication compliance, carelink transmissions, and randomization assignment.
- Subject has a CHADS2 score of ≥ 1.
Key exclusion criteria (4 listed)
- Subject has a medically documented history of paroxysmal or persistent atrial fibrillation or atrial flutter.
- Subject is pregnant.
- Subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician.
- Subject has previously or is scheduled to undergo valve repair or valve replacement during the course of the study.
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
The presence of AF at any post-operative points in time.
Time frame: 3 years
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 4 Nov 2016.
- Results publication: PubMed 27570120El-Chami MF, Merchant FM, Smith P, Levy M, Nelms AG, Merlino J, Puskas J, Leon AR. Management of New-Onset Postoperative Atrial Fibrillation Utilizing Insertable Cardiac Monitor Technology to Observe Recurrence of AF (MONITOR-AF). Pacing Clin Electrophysiol. 2016 Oct;39(10):1083-1089. doi: 10.1111/pace.12949. Epub 2016 Sep 22.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Mikhael F El Chami, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Coronary Artery Disease, run by Emory University at 1 site 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 7 inclusion and 4 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The presence of AF at any post-operative points in time. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01395836, which also lists 1 linked publication.
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 4 Nov 2016.