Follow-up on Abbott annuloplasty devices for heart valve repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ARB-PMCF study is a multicenter, observational study assessing the safety and performance of Abbott annuloplasty devices used in surgical repairs for mitral and tricuspid valve regurgitation. It involves enrolling up to 550 adult participants who are expected to undergo cardiac surgery within 90 days, with follow-up visits conducted annually for five years post-implant. The study aims to collect data on adverse events, medication usage, functional classification, and echocardiographic assessments to fulfill post-market clinical follow-up requirements in the EU. Participants will be grouped based on the type of annuloplasty device used and the nature of their valve disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Tartu University Hospital
  Tartu, Estonia Recruiting
• Hopital Cardiovasculaire et Pneumologique Louis Pradel
  Lyon, Auvergne-Rhône-Alpes, France Recruiting
• CHU de Besançon - Jean Minjoz
  Besançon, Bourgogne-Franche-Comté, France Recruiting
• Herzchirurgische Abteilung Klinikum Passau
  Passau, Bavaria, Germany Recruiting
• Herzzentrum-Bremen Klinikum Links der Weser
  Bremen, Free Hanseatic City of Bremen, Germany Recruiting
• Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
  Dresden, Saxony, Germany Recruiting

Study contacts

• Study coordinator: Karine Miquel
• Email: karine.miquel@abbott.com
• Phone: +32 479 60 01 07

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.