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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02722551
Eligibility Criteria:
Inclusion Criteria:
* NYHA ≥ II
* Moderate/severe or severe mitral regurgitation
* Prohibitive risk for open-heart surgery
* Meets anatomical criteria
Exclusion Criteria:
* Unsuitable anatomy
* Need for emergent or urgent surgery
* Prior mechanical aortic valve replacement
* Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve
* Preexisting device in the left ventricular apex
* Clinically significant, untreated coronary artery disease
* Limited life expectancy (\< 12 months)
* Active infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02722551
Study Brief:
Protocol Section:
NCT02722551