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

RecruitingOBSERVATIONAL
Enrollment

550

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

November 30, 2030

Study Completion Date

March 31, 2031

Conditions
Mitral RegurgitationTricuspid RegurgitationValvular Heart Disease
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.

Trial Locations (17)

1350

RECRUITING

Ospedale San Raffaele - Cardiac, Milan

10128

RECRUITING

Ospedale Umberto I, Turin

20157

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

WITHDRAWN

Ospedale Luigi Sacco, Milan

25000

RECRUITING

CHU de Besançon - Jean Minjoz, Besançon

27710

WITHDRAWN

Duke University Hospital, Durham

28211

RECRUITING

Herzzentrum-Bremen Klinikum Links der Weser, Bremen

36312

RECRUITING

Hospital Alvaro Cunqueiro, Vigo

40138

RECRUITING

Policlinico S.Orsola-Malpighi, Bologna

50406

RECRUITING

Tartu University Hospital, Tartu

53792

WITHDRAWN

University of Wisconsin Hospital and Clinics, Madison

69500

RECRUITING

Hopital Cardiovasculaire et Pneumologique Louis Pradel, Lyon

94032

RECRUITING

Herzchirurgische Abteilung Klinikum Passau, Passau

97080

COMPLETED

Universitätsklinikum Würzburg, Würzburg

01307

RECRUITING

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden, Dresden

07740

RECRUITING

Universitätsklinikum Jena, Jena

5623 EJ

RECRUITING

Catharina Ziekenhuis, Eindhoven

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY