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.
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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

Karine Miquel

+32 479 60 01 07

karine.miquel@abbott.com

CONTACT

Leslie Ornelas

+14803067436

leslie.ornelas@abbott.com

CONTACT