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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT05150366
Eligibility Criteria:
Inclusion Criteria:
* Man or woman over 18 years-old
* Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants
* Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
* Patient in sinus rhythm
* Subject affiliated or beneficiary of a social security scheme
* Patient having signed the informed consent
Exclusion Criteria:
* Patient participating in another clinical study
* Patient in permanent ACFA
* Patient with a mitral prosthesis (biological or mechanical),
* Patient with a history of mitral annuloplasty
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant, breastfeeding or parturient woman;
* Patient hospitalized without consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05150366
Study Brief:
Protocol Section:
NCT05150366