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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT03974269
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring transfemoral approach TAVI without general anesthesia
* For adult patients : age greater than or equal to 18 years
* Patients affiliated to a social security scheme
Exclusion Criteria:
* Patient whose age is less than 18 years
* Approach with general anesthesia
* Patient not responding to Hypnosis: unmotivated, non-cooperating, not confident
* Other than transfemoral approach : carotid, trans-apical or sternotomy or thoracotomy procedure
* chronic psychosis, bilateral deafness without hearing aids,
* emergency procedure,
* inability to communicate (severe dementia, non-French speaker),
* declined participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03974269
Study Brief:
Protocol Section:
NCT03974269