✓. implant of a full Tailor Ring without cut zone removal for TR repair, or
✓. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.
✓. Subject's cardiac surgery will be performed by a study investigator.
✓. Subject will be ≥18 years old at the time of their annuloplasty implant(s).
✓. Subject provides written informed consent and agrees to comply with all required study visits and procedures.
Exclusion criteria
✕. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.
✕. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
What they're measuring
1
Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant
Timeframe: 5 years
2
Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant
Timeframe: 5 years
3
Percentage of Participants in Each Tricuspid Treatment Group with at least a 1-Class Reduction in New York Heart Association (NYHA) Functional Classification at 1 Year Post-Implant.
✕. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).
✕. 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).
✕. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.
✕. 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