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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitralStitch repair system | Experimental | Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitralStitch | Device | With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiqiang Yu | Xijing Hospital | Principal Investigator |
| Jian Yang | Xijing Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |