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Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Sponsor: Abbott Medical Devices
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.
Official title: Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
550
Start Date
2021-02-01
Completion Date
2031-03
Last Updated
2025-07-09
Healthy Volunteers
No
Interventions
Abbott SJM Rigid Saddle Ring
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.
Abbott SJM Séguin Ring
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.
Abbott SJM Tailor Ring
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.
Abbott SJM Tailor 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)
Duke University Hospital
Durham, North Carolina, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Tartu University Hospital
Tartu, Estonia
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes, France
CHU de Besançon - Jean Minjoz
Besançon, Bourgogne-Franche-Comté, France
Herzchirurgische Abteilung Klinikum Passau
Passau, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Herzzentrum-Bremen Klinikum Links der Weser
Bremen, City state Bremen, Germany
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, Saxony, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Policlinico S.Orsola-Malpighi
Bologna, Bologna, Italy
Ospedale San Raffaele - Cardiac
Milan, Lombardy, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombard, Italy
Ospedale Luigi Sacco
Milan, Milan, Italy
Ospedale Umberto I
Turin, Piedmont, Italy
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain