Management of New-Onset Postoperative Atrial Fibrillation (Monitor-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.
Coronary Artery Disease
Post Operative Arrythmia
|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|
- The presence of AF at any post-operative points in time. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|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)|
The "treatment" group will be medically managed based on data obtained from monthly transmissions of the implanted Cardiac Monitor.
The "control" group will be managed in the usual standard of care with physicians blinded to their ICM data.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395836
|Contact: Paige F Smith, RN, MSemail@example.com|
|Contact: Mathew Levyfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Hospital Midtown||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Paige F Smith, RN 404-686-7992 email@example.com|
|Principal Investigator:||Mikhael F El Chami, MD||Emory University|