About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

This study will enroll male and female adult subjects from the general population of cardiac surgery patients who are expected to be implanted with a Rigid Saddle, Séguin or full Tailor Ring for mitral regurgitation (MR) repair, a full Tailor Ring for tricuspid regurgitation (TR) repair or a Tailor Band or partial Tailor Ring for primary TR repair within 90 days.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Abbott SJM Rigid Saddle Ring
Device
The Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole.
Abbott SJM Séguin Ring
Device
The Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion.
Abbott SJM Tailor Ring
Device
The Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band.
Abbott SJM Tailor Band
Device
The Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing.

Treatment groups

550 Participants

are divided into 5 treatment groups

Group A: Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant3 interventions

Group B: Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant3 interventions

Group C: Group 3: Primary tricuspid disease repair surgery with a full Tailor Ring implant1 intervention

Group D: Group 4: Secondary tricuspid disease repair surgery with a full Tailor Ring implant1 intervention

Group E: Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant

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.

Time frame

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

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.

Time frame

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.

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.

Time frame

1 year

Secondary outcomes

1

Number of Participants in Each Treatment Group by Grade of Regurgitation in the Valve Undergoing Repair, Pre-Operatively, at Discharge, and at 1, 3 and 5 Years Post-Implant

This outcome will be reported for each treatment group separately at each timepoint. Regurgitation occurs when a heart valve does not fully seal, allowing backflow of blood through the closed valve. Mitral and tricuspid valve regurgitation in this study will be graded as none/trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance.

Time frame

Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant

2

Number of Participants in Each Treatment Group by NYHA Functional Class, Pre-Operatively and at Discharge, 1, 3 and 5 Years Post-Implant.

This outcome will be reported for each treatment group separately at each timepoint. 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.

Time frame

Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant