Multicenter International Trial Ring AnnulopLasty

Study Overview
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Brief Summary
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This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.

Official Title
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Multicenter International Trial Ring AnnulopLasty

Conditions
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Mitral Valve Insufficiency

Intervention / Treatment
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* Device: mitral valve repair (SJM® Rigid Saddle Ring)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study); Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements; Patients are at least 18 years old. Exclusion Criteria: Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve; Patient is pregnant or nursing; Patient has active endocarditis; Patient is actively participating in another study of an investigational drug or device; Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...); Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent; Patients with a major non-cardiac evolving disease; Patients with a life expectancy less than 1 year; Patients are known to be noncompliant or are unlikely to complete the study; Any case in which mitral annuloplasty rings are not indicated;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SJM® Rigid Saddle Ring<br>The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff. | Device: mitral valve repair (SJM® Rigid Saddle Ring)<br>* mitral valve repair due to mitral degenerative or functional disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative). |  | 6 months | 
| NYHA class |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events rates |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral valve, heart valve, valve repair, valve disorder, valve disease, cardiac surgery