Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
Abbott Medical Devices
550 participants
Feb 1, 2021
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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.
Exclusion Criteria6
- 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).
- 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
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Interventions
The Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole.
The Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion.
The Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band.
The Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing.
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT04761120