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

ConditionsMitral Regurgitation Tricuspid Regurgitation Valvular Heart Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAbbott Medical Devices

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

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).