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

NCT Number	NCT04761120
Lead Sponsor	Abbott Medical Devices
Conditions	Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
Enrollment	550 participants
Start Date	2021-02-01
Primary Completion	2030-11 (estimated)
Study Completion	2031-03 (estimated)
Updated on ClinicalTrials.gov	2026-05-18