Status:
UNKNOWN
PREdicting Atrial Fibrillation or Flutter
Lead Sponsor:
Keesler Air Force Base Medical Center
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monit...
Detailed Description
Background: Atrial fibrillation and atrial flutter (AF) are common cardiac arrhythmias that confer a substantial stroke burden largely because the vast majority of AF is asymptomatic and identified af...
Eligibility Criteria
Inclusion
- Patient meets the approved FDA indication to receive the ICM
- Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator
- Patient has a CHA2DS2-VASc score ≥ 2 \[Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.\]
- Patient is 18 years of age or older
- Patient has a life expectancy of 18 months or more
Exclusion
- Patient has a documented history of AF or atrial flutter
- Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use)
- Patient had an ischemic stroke or TIA within past year prior to enrollment
- Patient has a history of a hemorrhagic stroke
- Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator)
- NYHA Class IV Heart Failure patient
- Patient had heart surgery within previous 90 days prior to enrollment
- Patient had an MI within the previous 90 days prior to enrollment
- Patient is taking chronic immunosuppressant therapy
- Patient is taking an anti-arrhythmic drug
- Patient is contraindicated for long term anticoagulation medication
- Patient is taking a long-term anticoagulation medication
- Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis)
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from the principal investigator
- Patient has a creatinine clearance \<30 ml/min or is on dialysis
- Active pregnancy
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01851902
Start Date
May 1 2013
End Date
June 1 2016
Last Update
January 5 2016
Active Locations (1)
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1
Keesler Medical Center
Keesler Air Force Base, Mississippi, United States, 39534