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

Description

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

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Study Overview

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Study Details

Study overview

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.

Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study

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

Condition
Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Hospital, Durham, North Carolina, United States, 27710

Madison

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Vinny Podichetty, STUDY_DIRECTOR, Abbott

Study Record Dates

2031-03