Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
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
🗓️ Study Start (Actual) 1 February 2021
🗓️ Primary Completion (Estimated) November 2030
✅ Study Completion (Estimated) March 2031
👥 Enrollment (Estimated) 550
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Durham, North Carolina, United States
📍 Madison, Wisconsin, United States
📍 Tartu, Estonia
📍 Lyon, Auvergne-Rhône-Alpes, France
📍 Besançon, Bourgogne-Franche-Comté, France
📍 Passau, Bavaria, Germany
📍 Würzburg, Bayern, Germany
📍 Dresden, Saxony, Germany
📍 Jena, Thuringia, Germany
📍 Bremen, Germany
📍 Milano, Lombardy, Italy
📍 Milan, Lombard, Italy
📍 Torino, Piemonte, Italy
📍 Bologna, Italy
📍 Milan, Italy
📍 Eindhoven, Noord-Brabant, Netherlands
📍 Vigo, Pontevedra, Spain

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 February 2021
  • First Submitted that Met QC Criteria 17 February 2021
  • First Posted 18 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 September 2023
  • Last Update Posted 21 September 2023
  • Last Verified September 2023