Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study (NCT04761120) | Clinical Trial Compass
RecruitingNot Applicable
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
United States, Estonia, France550 participantsStarted 2021-02-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant
Timeframe: 5 years
2
Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant
Timeframe: 5 years
3
Percentage of Participants in Each Tricuspid Treatment Group with at least a 1-Class Reduction in New York Heart Association (NYHA) Functional Classification at 1 Year Post-Implant.
. 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