Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study — ARB-PMCF  

Mitral Regurgitation Clinical Trial

Official title: Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Valvular Heart Disease

• NCT number: NCT04761120
• Study type: Observational
• Source: Abbott Medical Devices
• Contact: Karine Miquel
• Phone: +32 479 60 01 07
• Email: karine.miquel@abbott.com
• Status: Recruiting
• Start date: February 1, 2021
• Completion date: March 2031