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RECRUITING
NCT04761120

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

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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