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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT04761120
Eligibility Criteria:
Inclusion Criteria:
1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:
1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair
2. implant of a full Tailor Ring without cut zone removal for TR repair, or
3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.
2. Subject's cardiac surgery will be performed by a study investigator.
3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).
4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.
Exclusion Criteria:
1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.
2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).
4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s).
5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.
6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04761120
Study Brief:
Protocol Section:
NCT04761120