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

Recruitingn/aAges 18 Years - anyAllAbbott Medical Devices
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Abbott SJM Rigid Saddle Ring
  • Abbott SJM Séguin Ring
  • Abbott SJM Tailor Ring
  • Abbott SJM Tailor Band
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Where

17 sites
Duke University Hospital
Durham, United States
University of Wisconsin Hospital and Clinics
Madison, United States
Tartu University Hospital
Tartu, Estonia
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, France
CHU de Besançon - Jean Minjoz
Besançon, France
Herzchirurgische Abteilung Klinikum Passau
Passau, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Herzzentrum-Bremen Klinikum Links der Weser
Bremen, Germany

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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