Updated on 25 March 2021




Prospective, single arm, open-label, multicenter, post-market interventional clinical study to determine, via continuous monitoring with the Reveal XT implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how physicians manage these patients once AF has been detected.

Condition Atrial Fibrillation, Arrhythmia
Clinical Study IdentifierTX137362
Last Modified on25 March 2021


Yes No Not Sure

Inclusion Criteria

Patient is suspected of having Atrial Fibrillation (AF) or at high risk of having AF
Patient has a CHADS2 (Congestive heart Failure, HTN, Age >75, Diabetes Mellitus, prior Stroke) score = 3 OR has a CHADS2 score = 2 with at least one of the following documented
Coronary artery disease
Renal impairment (GFR 30-60 ml/min)
Sleep apnea
Chronic obstructive pulmonary disease

Exclusion Criteria

Documented history of AF or Atrial Flutter
Ischemic Stroke or TIA within past year prior to enrollment
History of a Hemorrhagic Stroke
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How to participate?

Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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