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 @ 7:33 PM
Ignite Modification Date:
2025-12-24 @ 7:33 PM
NCT ID:
NCT04347603
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years of age
* Consecutive patients referred to the cardiology department of the CHU in Montpellier, France, for TAVI via transfemoral access.
* Patients for whom the procedure is indicated after decision by the heart team and according to the current recommendations of the European Society of Cardiology.
* Patients with severe aortic stenosis defined by mean gradient \> 40 mmHg and/or aortic valve area 1 cm2 or 0.8 cm2/m2 as recommended. May also include patients with low gradient (\< 40mm hg) and low flow (stroke volume index \< 35ml/minute) which are classic indications for aortic valve replacement
* Ability to consent to participate in study
* Patient affiliated with or beneficiary of a social security scheme
Exclusion Criteria:
* Chronic respiratory insufficiency treated by long term oxygeno therapy
* Pulmonary hypertension above 50mmHg
* BMI\>35
* TAVI by carotidian or apical way
* Pregnant women
* Vulnerable person according to L1121-6 of Public Health reglementation in France
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04347603
Study Brief:
Protocol Section:
NCT04347603