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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT05330468
Eligibility Criteria:
Inclusion Criteria:
1. Patient is eligible to be implanted with Regent to replace a native or prosthetic aortic valve per Regent's IFU.
2. Subject will be \>18 years of age at time of being consented.
3. Subject, provides written informed consent prior to any clinical investigation-specific procedure.
Exclusion Criteria:
1. Subject is unable to tolerate anticoagulation therapy.
2. Subject has active endocarditis.
3. Subject is currently participating in another clinical investigation which may interfere with the effectiveness of anticoagulation therapy.
4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Women of child-bearing potential must have a documented negative pregnancy test within one week prior to enrollment.
5. Subject has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
6. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
7. Subject's life expectancy is less than 1 year in the opinion of the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05330468
Study Brief:
Protocol Section:
NCT05330468