Management of New-Onset Postoperative Atrial Fibrillation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2011 |
| End Date: | October 2016 |
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.
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.
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.
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