Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.
• Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:
‣ implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair
⁃ 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.