MitralStitch Mitral Valve Repair System for Mitral Regurgitation

Study Overview
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Brief Summary
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The main objective is to assess the effectiveness and safety of the MitralStitch repair system in patients with moderate to severe and severe mitral regurgitation.

Official Title
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To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: MitralStitch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of patient is ≥18yrs; Severe mitral regurgitation patients (The area of central regurgitation exceeds 40% of left atrial area or holosystolic eccentric regurgitation; VC≥0.07cm；regurgitant volume ≥60ml；RF ≥50%; EROA≥0.4cm2 (Satisfy any condition). LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated. The subject was informed of the clinical application nature of the new technology and agreed to participate in all requirements of the clinical application of the new technology, signed the ICF and agreed to complete the follow-up and the inspection required during the follow-up period. Exclusion Criteria: Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology. Subjects with active endocarditis or rheumatic mitral valve disease. Life expectancy <1 year for cardiac or other malignant tumors. Participate in other clinical trial In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.

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: MitralStitch repair system<br>Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd | Device: MitralStitch<br>* With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence rate of major adverse event after 30 days of the intervention | The occurrence of complications associated with any device or operation, including but not limited to: death, emergency surgery, severe pericardial tamponade requiring pericardiac puncture or surgery, bleeding, and surgically related stroke. | 30days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success of device | The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully. | Immediately after repair | 
| The success rate of operation | Mitral regurgitation was less than moderate before discharge. | Before discharge, an average of 7 days | 
| Incidence of major adverse events after device implantation | There were no major adverse events associated with device or operation within 12 months of device implantation. | 12months | 
| The classification of mitral regurgitation | Mild: No mitral regurgitation or the centricity regurgitation area is smaller than the 20% of left atrial area. Moderate: The area of centricity regurgitation is upper than 40%, lower than 60% of the left atrial area; VC≥0.7cm; regurgitant volume≥60ml； RF≥50%; EROA≥0.4cm². Severe: The area of centricity regurgitation is upper than 40% of the left atrial area or systolic eccentric regurgitation. | 1/6/12 months |