Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Recruiting
Observational Study
Mitral Regurgitation
Tricuspid Regurgitation
Valvular Heart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 550 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
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About This Trial
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 mi…
Trial Locations
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Eligibility Criteria
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…
Contacts