NCT04761120Recruiting

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

Abbott Medical Devices

Start Date

2/1/2021

Completion Date

3/1/2031

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.

Detailed Description

The ARB-PMCF Study has a prospective, multicenter, observational, parallel group design in which up to 550 subjects will be followed through five years from implant of an Abbott annuloplasty device, with or without concomitant procedures, in five treatment groups, including primary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal; secondary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring; primary tricuspid disease repair with the full Tailor Ring (N=50); secondary tricuspid disease repair with the full Tailor Ring (N=50); and primary tricuspid disease repair with the Tailor Band or partial Tailor Ring with cut zone removed (N=50). Study enrollment will occur at up to 25 global centers with approximately half or more of all implanted subjects being from European sites. The study will enroll adult subjects expected to be implanted with an Abbott annuloplasty device within 90 days who meet all other eligibility requirements. Participants will complete annual in-clinic or telephone follow-up visits through five years from their annuloplasty implant. Data collected will include adverse events, cardiac medication usage, New York Heart Association functional classification (a measure of the severity of heart failure symptoms) and echocardiographic assessments of regurgitation through the repaired valve.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Abbott SJM Rigid Saddle Ring

DEVICE

Abbott SJM Séguin Ring

DEVICE

Abbott SJM Tailor Ring

DEVICE

Abbott SJM Tailor Band

Hospital Alvaro Cunqueiro

Vigo, Pontevedra 36312

Spain