Status:
RECRUITING
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Mitral Regurgitation
Tricuspid Regurgitation
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
The ARB-PMCF Study has a prospective, multicenter, observational, parallel group design in which up to 550 subjects will be followed through five years from implant of an Abbott annuloplasty device, w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04761120
Start Date
February 1 2021
End Date
March 1 2031
Last Update
July 9 2025
Active Locations (17)
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1
Duke University Hospital
Durham, North Carolina, United States, 27710
2
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
3
Tartu University Hospital
Tartu, Estonia, 50406
4
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes, France, 69500