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.
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…
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.
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…
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 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.
Exclusion Criteria:
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
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