Annuloplasty Devices for Mitral and Tricuspid Valve Repair

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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
550 (estimated)
Sponsor
Abbott Medical Devices · Industry
Who this trial is looking for

This trial is looking for patients who need surgery to fix their heart valves. Participants will receive a specific type of heart device and will visit the clinic for follow-ups for five years.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am going to have heart surgery within 90 days.
  • I will receive an Abbott annuloplasty device during my surgery.
  • I am at least 18 years old.
  • I can provide written consent for the trial.

You may not be able to join if

  • I am below the legal age to give consent.
  • I cannot read or write or have a mental condition affecting my consent.
  • I have active endocarditis at the time of my surgery.
  • I am involved in another clinical study.
  • I have health conditions that would prevent me from participating.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
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