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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT05526560
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older at the time of informed consent
* Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
* Provides written informed consent
* Willingness to follow protocol requirements
Exclusion Criteria:
* Active endocarditis 3 months prior to the procedure
* Stage 4 renal disease or requiring dialysis
* Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
* High predicted risk of mortality prior to procedure
* Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of \> 8 or
* Surgeon estimated risk of mortality of \> 8
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05526560
Study Brief:
Protocol Section:
NCT05526560