Observational Study of Abbott Annuloplasty Devices for Mitral and Tricuspid Valve Repair
This study is observing how well different Abbott annuloplasty devices work in people needing heart valve repair. These devices include the Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring, Abbott SJM Tailor Ring, and Abbott SJM Tailor Band. They are used to help repair mitral regurgitation (a leaky mitral valve) or tricuspid regurgitation (a leaky tricuspid valve). You might be able to join if you are an adult having heart surgery within 90 days that includes one of these devices. Researchers will look at how many people are still alive after 5 years, how many people need another surgery for mitral regurgitation after 5 years, and if people with tricuspid regurgitation feel better after 1 year. The study is currently unclear on its recruitment status and aims to enroll up to 550 participants.
- Study design
- This is an observational study, meaning researchers will watch how participants do over time without assigning treatments. Up to 550 participants will be followed in five different groups.
- What's involved
- Participants will have annual follow-up visits, either in person or by phone, for up to five years after their device is implanted.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to five years after their device implant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
At a glance
Conditions
Where it's being run
17 sites across 16 statesStudy leadership
- Ryan Palmer · STUDY_DIRECTOR · Abbott
Who to contact
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What this trial measures
- Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant5 years
Percentage of participants in each study treatment group (Groups 1 through 5) who are free of death from any cause through 5 years after their Abbott annuloplasty device implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported for each treatment group separately.
- Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant5 years
Percentage of participants in each mitral treatment group (Groups 1 and 2) who are free from reoperation or transcatheter intervention for mitral regurgitation through 5 years after their Abbott annuloplasty implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported separately for Group 1 and Group 2.
- 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.1 year
This outcome will be reported for each tricuspid repair group (Groups 3 through 5) separately. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes: Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.