Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT01851902
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01851902
Study Brief:
Protocol Section:
NCT01851902