Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

Launched by ABBOTT MEDICAL DEVICES · Feb 17, 2021

Keywords

ClinConnect Summary

The Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study is looking at the safety and effectiveness of specific heart devices made by Abbott. These devices are used to repair problems with the mitral and tricuspid valves in the heart, conditions known as mitral regurgitation and tricuspid regurgitation, which can lead to heart issues. If you are 18 years or older and are scheduled for heart surgery within the next 90 days that involves one of these Abbott devices, you might be eligible to join the study. Participants will need to give their consent and agree to attend follow-up visits once a year for five years after their surgery.

The study is currently recruiting participants, and it’s important to know that not everyone can take part. For example, individuals with certain medical conditions or those who are participating in other clinical trials may be excluded. If you join, you will help researchers understand how well these devices work in real-life situations after surgery, which is important information for future patients. This study is part of a requirement to monitor medical devices after they are approved for use.

Gender

ALL

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