St. Jude Medical Percutaneous Mitral Valve Repair Study

Study Overview
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Brief Summary
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The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.

Detailed Description
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Subjects will be followed-up through 6 weeks post implantation.

Official Title
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Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept

Conditions
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Mitral Valve Prolapse

Intervention / Treatment
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* Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation. Subject has an ejection fraction (EF) ≥ 30%. Subject is of legal age (≥18 years old). Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse. Exclusion Criteria: Subject requires a complex mitral valve repair or has isolated anterior prolapse. Subject has mitral valve stenosis in which the annulus opening is <10mm. Subject has valve disease other than mitral which requires surgical intervention. Subject requires a concomitant procedure. Subject has a pre-existing prosthetic valve in any position. Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure. Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device. Subject has renal insufficiency or is on chronic dialysis. Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months. Subject has a history of endocarditis or has active endocarditis. Subject has a history of autoimmune disease. Subject has significant known carotid artery disease. Subject has an aorto-mitral angle of <110 degrees. Subject has hypertrophic obstructive cardiomyopathy (HOCM's Disease).

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 |
| --- | --- |
| Experimental: Intevention-PMVr Procedure<br> | Device: PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)<br>* A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device and Procedural Success | The primary objective is to evaluate the technical feasibility and acute device deployment characteristics of the SJM PMVr Device. Technical feasibility and deployment characteristics will be defined as: The ability of the delivery system to access the mitral valve The ability of the device to capture mitral valve (MV) leaflet tissue Ability to plicate MV leaflet tissue The clip is able to be deployed in MV leaflet tissue The delivery system is able to be removed. | During the investigational procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of SAEs reported that are unique to the investigational procedure | The secondary objective is to evaluate safety of the SJM PMVr device by summarizing SAEs unique to accessing the valve, placing the clip, and removing the delivery system. | Through 6 weeks post-implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Valve Prolapse, Mitral Valve Disease, Mitral Valve Regurgitation, Mitral Valve Insufficiency, Mitral Valve Incompetence, Percutaneous Mitral Valve Repair, Posterior leaflet prolapse, Mitral valve degeneration