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

Recruiting now

Conditions studied: Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease

In brief

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.

Key facts

Study ID

NCT04761120

Run by

Abbott Medical Devices

People needed

550

Starts

2021-02-01

Expected to finish

2031-03-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Hospital Alvaro Cunqueiro — Vigo, Pontevedra, Spain (enrolling)
• Ospedale San Raffaele - Cardiac — Milan, Lombardy, Italy (enrolling)
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Lombard, Italy (enrolling)
• Ospedale Umberto I — Turin, Piedmont, Italy (enrolling)
• Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands (enrolling)
• Tartu University Hospital — Tartu, Estonia (enrolling)
• Hopital Cardiovasculaire et Pneumologique Louis Pradel — Lyon, Auvergne-Rhône-Alpes, France (enrolling)
• CHU de Besançon - Jean Minjoz — Besançon, Bourgogne-Franche-Comté, France (enrolling)
• Herzchirurgische Abteilung Klinikum Passau — Passau, Bavaria, Germany (enrolling)
• Herzzentrum-Bremen Klinikum Links der Weser — Bremen, Free Hanseatic City of Bremen, Germany (enrolling)
• Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden — Dresden, Saxony, Germany (enrolling)
• Universitätsklinikum Jena — Jena, Thuringia, Germany (enrolling)
• Policlinico S.Orsola-Malpighi — Bologna, Bologna, Italy (enrolling)
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Duke University Hospital — Durham, North Carolina, United States
• Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany
• Ospedale Luigi Sacco — Milan, Milan, Italy

Full record on ClinicalTrials.gov

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