PRESERVE-MITRAL Post-Market Registry

Study Overview
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Brief Summary
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The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure

Detailed Description
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There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes. Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation. PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure

Official Title
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Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia

Conditions
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Mitral Valve Disease

Intervention / Treatment
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* Device: Profile 3D™ and CG Future® annuloplasty system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG Future® annuloplasty systems Indications and contraindications provided in the product Instructions for Use Subject is 18 years of age or older The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements Exclusion Criteria: Contraindications as per instructions-for-use (IFU): Heavily calcified valves Valvular retraction with severely reduced mobility Active bacterial endocarditis Aortic valve replacement as concomitant procedure Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Profile 3D™ and CG Future® annuloplasty system|Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Mitral Regurgitation (MR) grade | Improvement in Mitral Regurgitation grade | 12 months | 
| All cause mortality | All deaths occurring from any cause post procedure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient baseline and pathophysiology | Characterization of patient baseline demographics age, sex, height (cm), weight (kg) and pathophysiology of mitral valve disease | 12 months | 
| Improvement in MR grade at discharge and first follow up |  | 3-6 months | 
| Improvement in New York Heart Association (NYHA) functional class at discharge, first follow up (3-6 months) and second follow up (12 months) compared to baseline |  | At 7 days post procedure, 3-6 months & 12 months | 
| Hospitalization for Heart Failure at 6 months and at 12 months post procedure |  | 6 months and 12 months post procedure | 
| Mitral valve re-intervention at discharge, 6 months and at 12 months post procedure |  | At 7 days post procedure, 6 months and 12 months post procedure | 
| Stroke at 6 months and at 12 months post procedure |  | 6 months and 12 months post procedure | 
| New onset of Atrial Fibrillation at discharge, first follow up (3-6 months) and at second follow up (12 months) | As evaluated through follow up ECG | At 7 days post procedure, 3-6 months, 12 months | 
| Procedure details | Number of attempts required for procedural success, and bypass time as a measure of procedural complexity, as measured by standard operating room procedures at the site. | During the procedure |