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

NCT04761120 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10368
• Study Type: observational
• Target: 550
• Locations: 6 countries
• Sites: 16

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.

Conditions

Mitral Regurgitation; Tricuspid Regurgitation; Valvular Heart Disease

Keywords

Mitral Regurgitation; Tricuspid Regurgitation; Valve Surgery; Valve Repair; Annuloplasty Rings; Annuloplasty Bands; Rigid Saddle Ring; Séguin Annuloplasty Ring; Tailor Annuloplasty Ring; Tailor Annuloplasty Band

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant

  Percentage of participants in each study treatment group (Groups 1 through 5) who are free of death from any cause through 5 years after their Abbott annuloplasty device implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported for each treatment group separately.

  5 years

• Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant

  Percentage of participants in each mitral treatment group (Groups 1 and 2) who are free from reoperation or transcatheter intervention for mitral regurgitation through 5 years after their Abbott annuloplasty implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported separately for Group 1 and Group 2.

  5 years

• Percentage of Participants in Each Tricuspid Treatment Group with at least a 1-Class Reduction in New York Heart Association (NYHA) Functional Classification at 1 Year Post-Implant.

  This outcome will be reported for each tricuspid repair group (Groups 3 through 5) separately. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes: Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

  1 year

Secondary Outcomes (2)

• Number of Participants in Each Treatment Group by Grade of Regurgitation in the Valve Undergoing Repair, Pre-Operatively, at Discharge, and at 1, 3 and 5 Years Post-Implant

  Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant

• Number of Participants in Each Treatment Group by NYHA Functional Class, Pre-Operatively and at Discharge, 1, 3 and 5 Years Post-Implant.

  Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant

Study Arms (5)

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.

Device: Abbott SJM Rigid Saddle Ring; Device: Abbott SJM Séguin Ring; Device: Abbott SJM Tailor Ring

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.

Device: Abbott SJM Rigid Saddle Ring; Device: Abbott SJM Séguin Ring; Device: Abbott SJM Tailor Ring

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.

Device: Abbott SJM Tailor Ring

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.

Device: Abbott SJM Tailor Ring

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.

Device: Abbott SJM Tailor Ring; Device: Abbott SJM Tailor Band

Interventions

Abbott SJM Rigid Saddle Ring 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.

Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant; Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant

Abbott SJM Séguin Ring 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.

Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant; Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant

Abbott SJM Tailor Ring 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 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant; Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant; Group 3: Primary tricuspid disease repair surgery with a full Tailor Ring implant; Group 4: Secondary tricuspid disease repair surgery with a full Tailor Ring implant; Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant

Abbott SJM Tailor Band 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll male and female adult subjects from the general population of cardiac surgery patients who are expected to be implanted with a Rigid Saddle, Séguin or full Tailor Ring for mitral regurgitation (MR) repair, a full Tailor Ring for tricuspid regurgitation (TR) repair or a Tailor Band or partial Tailor Ring for primary TR repair within 90 days.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (17)

Duke University Hospital

Durham, North Carolina, 27710, United States

WITHDRAWN

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

WITHDRAWN

Tartu University Hospital

Tartu, 50406, Estonia

RECRUITING

Hopital Cardiovasculaire et Pneumologique Louis Pradel

Lyon, Auvergne-Rhône-Alpes, 69500, France

RECRUITING

CHU de Besançon - Jean Minjoz

Besançon, Bourgogne-Franche-Comté, 25000, France

RECRUITING

Herzchirurgische Abteilung Klinikum Passau

Passau, Bavaria, 94032, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

COMPLETED

Herzzentrum-Bremen Klinikum Links der Weser

Bremen, City state Bremen, 28211, Germany

RECRUITING

Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, 07740, Germany

RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, Bologna, 40138, Italy

RECRUITING

Ospedale San Raffaele - Cardiac

Milan, Lombardy, 1350, Italy

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombard, 20157, Italy

RECRUITING

Ospedale Luigi Sacco

Milan, Milan, 20157, Italy

WITHDRAWN

Ospedale Umberto I

Turin, Piedmont, 10128, Italy

RECRUITING

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ryan Palmer

  Abbott

  STUDY DIRECTOR

Central Study Contacts

Karine Miquel

CONTACT

+32 479 60 01 07; karine.miquel@abbott.com

Leslie Ornelas

CONTACT

+14803067436; leslie.ornelas@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 18, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 9, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); DE (5); ES (1); IT (5); NL (1); US (2)