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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT06334250
Eligibility Criteria:
Inclusion Criteria:
* Paroxysmal or Persistent AF, aged 18-80
* Presence of symptoms attributable to AF: EHRA 2 and above
* Clinical indication for LAAO procedure
* Own smartphone compatible with AliveCor device
Exclusion Criteria:
* Permanent AF
* Body mass index ≥40
* Previous LA ablation procedure
* Severely enlarged LA (\>50mm antero-posterior diameter)
* Severely impaired left ventricular function (ejection fraction \< 35%)
* Severe valvular disease
* Significant renal impairment (estimated glomerular filtration rate \< 30)
* Pregnancy
* Significant frailty (Clinical Frailty Score \< 5)
* Non-AF arrhythmia (e.g., atypical flutter, focal atrial tachycardia, other narrow complex tachycardias)
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06334250
Study Brief:
Protocol Section:
NCT06334250