Study of Abbott Annuloplasty Rings and Band for Mitral and Tricuspid Valve Repair with 5-Year Follow-Up

What this Trial Is About

Researchers are observing the safety and performance of Abbott annuloplasty devices used in surgeries to repair mitral and tricuspid valve regurgitation. This study includes devices such as the SJM Rigid Saddle Ring, SJM Sguin Annuloplasty Ring, SJM Tailor Annuloplasty Ring, and SJM Tailor Annuloplasty Band. The trial aims to meet post-market clinical follow-up requirements and follows up with participants for five years after their valve repair surgery. Participants will be grouped based on their specific valve condition and the device implanted during surgery. The five groups include primary and secondary mitral disease repairs using different annuloplasty rings, as well as primary and secondary tricuspid disease repairs using the Tailor Ring or Tailor Band. Enrollment occurs before surgery, and subjects will be implanted with one of these Abbott devices as part of their standard surgical care. After implantation, participants will complete yearly follow-up visits either in clinic or by phone for up to five years. Data collected will include any adverse events, use of cardiac medications, heart failure symptom severity measured by the New York Heart Association functional classification, and echocardiographic assessments of valve regurgitation. The study will measure outcomes such as survival rates, need for reoperation or reintervention, and improvement in heart function over time.

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study