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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT07059793
Eligibility Criteria:
Inclusion Criteria:
1. 18 years or older at the time of informed consent
2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
3. Provide signed written informed consent prior to the study participation
4. Willingness to follow protocol requirements
Exclusion Criteria:
1. Active endocarditis 3 months prior to the procedure
2. Stage 4 renal disease or requiring dialysis (eGFR \< 30 is excluded)
3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
4. High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) \> 8 or Surgeon estimated risk of mortality of \> 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.)
5. Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07059793
Study Brief:
Protocol Section:
NCT07059793