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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT05061004
Eligibility Criteria:
Key Inclusion Criteria:
* Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.
* LVEF ≥ 30%
* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
Key Exclusion Criteria:
* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
* Need for emergent or urgent surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05061004
Study Brief:
Protocol Section:
NCT05061004