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

NCT ID: NCT04761120

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2031-03-31

Brief 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.

Detailed Description

The ARB-PMCF Study has a prospective, multicenter, observational, parallel group design in which up to 550 subjects will be followed through five years from implant of an Abbott annuloplasty device, with or without concomitant procedures, in five treatment groups, including primary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal; secondary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring; primary tricuspid disease repair with the full Tailor Ring (N=50); secondary tricuspid disease repair with the full Tailor Ring (N=50); and primary tricuspid disease repair with the Tailor Band or partial Tailor Ring with cut zone removed (N=50). Study enrollment will occur at up to 25 global centers with approximately half or more of all implanted subjects being from European sites. The study will enroll adult subjects expected to be implanted with an Abbott annuloplasty device within 90 days who meet all other eligibility requirements. Participants will complete annual in-clinic or telephone follow-up visits through five years from their annuloplasty implant. Data collected will include adverse events, cardiac medication usage, New York Heart Association functional classification (a measure of the severity of heart failure symptoms) and echocardiographic assessments of regurgitation through the repaired valve.

Conditions

Mitral Regurgitation; Tricuspid Regurgitation; Valvular Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant

Group 1 will enroll 200 subjects undergoing surgical repair of primary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In primary mitral regurgitation, backflow through the closed valve is caused by disease intrinsic to the mitral valve tissue itself.

Abbott SJM Rigid Saddle Ring

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant

Group 2 will enroll 200 subjects undergoing surgical repair of secondary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In secondary mitral regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself.

Abbott SJM Rigid Saddle Ring

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Group 3: Primary tricuspid disease repair surgery with a full Tailor Ring implant

Group 3 will enroll up to 50 subjects undergoing surgical repair of primary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself.

Abbott SJM Tailor Ring

Intervention Type: DEVICE

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.

Group 4: Secondary tricuspid disease repair surgery with a full Tailor Ring implant

Group 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In secondary tricuspid regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself.

Abbott SJM Tailor Ring

Intervention Type: DEVICE

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.

Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant

Group 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes posterior annuloplasty with either a partial Abbott SJM Tailor Ring with cut zone removed or an Abbott SJM Tailor Band. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself.

Abbott SJM Tailor Ring

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:

1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair

2. implant of a full Tailor Ring without cut zone removal for TR repair, or

3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.

2. Subject's cardiac surgery will be performed by a study investigator.

3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).

4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.

Exclusion Criteria

1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.

2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.

3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).

4. 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).

5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.

6. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Palmer

Role: STUDY_DIRECTOR

Abbott

Locations

Duke University Hospital

Durham, North Carolina, United States

Site Status: WITHDRAWN

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status: WITHDRAWN

Tartu University Hospital

Tartu, , Estonia

Site Status: RECRUITING

Hopital Cardiovasculaire et Pneumologique Louis Pradel

Lyon, Auvergne-Rhône-Alpes, France

Site Status: RECRUITING

CHU de Besançon - Jean Minjoz

Besançon, Bourgogne-Franche-Comté, France

Site Status: RECRUITING

Herzchirurgische Abteilung Klinikum Passau

Passau, Bavaria, Germany

Site Status: RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Site Status: COMPLETED

Herzzentrum-Bremen Klinikum Links der Weser

Bremen, City state Bremen, Germany

Site Status: RECRUITING

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, Germany

Site Status: RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, Bologna, Italy

Site Status: RECRUITING

Ospedale San Raffaele - Cardiac

Milan, Lombardy, Italy

Site Status: RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombard, Italy

Site Status: RECRUITING

Ospedale Luigi Sacco

Milan, Milan, Italy

Site Status: WITHDRAWN

Ospedale Umberto I

Turin, Piedmont, Italy

Site Status: RECRUITING

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Site Status: RECRUITING

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Site Status: RECRUITING

Countries

United States; Estonia; France; Germany; Italy; Netherlands; Spain

Central Contacts

Karine Miquel

Role: CONTACT

karine.miquel@abbott.com

+32 479 60 01 07

Leslie Ornelas

Role: CONTACT

leslie.ornelas@abbott.com

+14803067436

Facility Contacts

Prof Arno Ruusalepp, PhD

Role: primary

Prof Jean-François Obadia, MD

Role: primary

Dr Sidney Chocron, MD

Role: primary

Dr. Markus Czesla, MD

Role: primary

Dr Thorsten Schmidt, MD

Role: primary

Prof. Dr. Klaus Matschke, MD, PhD

Role: primary

Prof. Dr. Torsten Doenst, MD, PhD

Role: primary

Prof Davide Pacini, MD

Role: primary

Prof. Michele De Bonis, MD

Role: primary

Prof Carlo Antona, MDA

Role: primary

Dr Paolo Centofanti, MD

Role: primary

Dr Andrew Tjon, MD

Role: primary

Dr Juan José Legarra, MD

Role: primary

Other Identifiers

ABT-CIP-10368

Identifier Type: -

Identifier Source: org_study_id