Management of New-Onset Postoperative Atrial Fibrillation (Monitor-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Emory University
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Mikhael El Chami, Emory University
ClinicalTrials.gov Identifier:
NCT01395836
First received: July 14, 2011
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition
Atrial Fibrillation
Coronary Artery Disease
Post Operative Arrythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of New-Onset Postoperative Atrial Fibrillation Utilizing Insertable Cardiac Monitor Technology to Observe Recurrence of AF

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The presence of AF at any post-operative points in time. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing isolated CABG at Emory University Hospital Midtown will be followed post-operatively and screened for inclusion to the trial.

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395836

Contacts
Contact: Paige F Smith, RN, MS 404-686-7992 pfsmith@emory.edu
Contact: Mathew Levy 404-686-5974 mrlevy@emory.edu

Locations
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Paige F Smith, RN    404-686-7992    pfsmith@emory.edu   
Sponsors and Collaborators
Emory University
Medtronic
Investigators
Principal Investigator: Mikhael F El Chami, MD Emory University
  More Information

No publications provided

Responsible Party: Mikhael El Chami, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01395836     History of Changes
Other Study ID Numbers: IRB00047554a, EPEUHM
Study First Received: July 14, 2011
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Coronary Artery Bypass Grafting
Cardiology
Cardiac Electrophysiology
Cardiac Surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014