MitraClip NT System Post-marketing Surveillance Study - Japan

Study Overview
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Brief Summary
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The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

Detailed Description
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This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance. Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.

Official Title
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MitraClip NT System Post -Marketing Surveillance Study

Conditions
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Mitral Regurgitation, Mitral Valve Regurgitation

Intervention / Treatment
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* Device: MitraClip NT System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refer to MitraClip IFU Exclusion Criteria: Refer to MitraClip IFU

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MitraClip NT System<br>Percutaneous mitral valve repair using MitraClip NT System | Device: MitraClip NT System<br>* Percutaneous mitral valve repair using MitraClip NT System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single Leaflet Device Attachment (SLDA) Rate | SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device | up to 30 Days | 
| No of Participants With Acute Procedural Success (APS) | APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+). | up to 7 days (Discharge visit) from Procedure date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral Valve Regurgitation, MitraClip, MitraClip NT, Japan MitraClip NT Postmarketing Surveillance