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:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT04898361
Eligibility Criteria:
Inclusion Criteria:
* Previous embolic stroke with undetermined source with…
* palpitations with clinical indication for an electrophysiological study (control group)
* PFO and clinical indication for interventional PFO closure according to current guidelines (intervention group)
* Sinus rhythm at time of inclusion with no history of AF
* Planned EP study due to reported palpitations or documented burden of non-sustained atrial arrythymias (\>100 atrial ectopic beats /24 hours, atrial tachycardia)
* Written informed consent
Exclusion Criteria:
* previously documented AF
* indication for therapeutic anticoagulation
* uncontrolled diabetes mellitus
* acute coronary syndrom or acute cardiac decompensation within the last 6 months before enrollment
* enrolled in another study
* BMI \> 40 kg/m²
* patients who are pregnant of breastfeeding life expectancy \< 6 months
* relevant peripheral artery disease
* substance abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04898361
Study Brief:
Protocol Section:
NCT04898361