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

Last updated: February 7, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Cardiovascular Disease

Heart Disease

Treatment

Abbott SJM Séguin Ring

Abbott SJM Tailor Band

Abbott SJM Rigid Saddle Ring

Clinical Study ID

NCT04761120
ABT-CIP-10368
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cutzone removal for MR repair

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

  4. implant of a Tailor Band or partial Tailor Ring with cut zone removed forprimary TR repair.

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

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

  7. Subject provides written informed consent and agrees to comply with all requiredstudy visits and procedures.

Exclusion

Exclusion Criteria:

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

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

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

  4. Subject cannot be unambiguously assigned to a treatment group due to missing data onrepair indication(s) or the model and configuration (cut zone removed or not) oftheir Abbott annuloplasty implant(s).

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

  6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history orconditions that, in the investigator's opinion, would limit the subject's ability toparticipate in the clinical investigation or to comply with follow-up requirements

Study Design

Total Participants: 550
Treatment Group(s): 4
Primary Treatment: Abbott SJM Séguin Ring
Phase:
Study Start date:
February 01, 2021
Estimated Completion Date:
March 31, 2031

Study 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.

Connect with a study center

  • Tartu University Hospital

    Tartu, 50406
    Estonia

    Active - Recruiting

  • Hopital Cardiovasculaire et Pneumologique Louis Pradel

    Lyon, Auvergne-Rhône-Alpes 69500
    France

    Active - Recruiting

  • CHU de Besançon - Jean Minjoz

    Besançon, Bourgogne-Franche-Comté 25000
    France

    Active - Recruiting

  • Herzchirurgische Abteilung Klinikum Passau

    Passau, Bavaria 94032
    Germany

    Active - Recruiting

  • Universitätsklinikum Würzburg

    Würzburg, Bayern 97080
    Germany

    Site Not Available

  • Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

    Dresden, Saxony 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena

    Jena, Thuringia 07740
    Germany

    Active - Recruiting

  • Herzzentrum-Bremen Klinikum Links der Weser

    Bremen, 28211
    Germany

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombard 20157
    Italy

    Active - Recruiting

  • Ospedale San Raffaele - Cardiac

    Milano, Lombardy 1350
    Italy

    Active - Recruiting

  • Ospedale Umberto I

    Torino, Piemonte 10128
    Italy

    Active - Recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna, 40138
    Italy

    Active - Recruiting

  • Ospedale Luigi Sacco

    Milan, 20157
    Italy

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven, Noord-Brabant 5623 EJ
    Netherlands

    Active - Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra 36312
    Spain

    Active - Recruiting

  • Duke University Hospital

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

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