MitralStitch Mitral Valve Repair System for Mitral Regurgitation
NCT ID: NCT04061837
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2019-08-23
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MitralStitch repair system
Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd
MitralStitch
With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System
Interventions
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MitralStitch
With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. LVESD≤60mm, LVEF≥25%, small incision surgery of chest can be tolerated.
4. 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
2. Subjects with active endocarditis or rheumatic mitral valve disease.
3. Life expectancy \<1 year for cardiac or other malignant tumors.
4. Participate in other clinical trial
5. In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
18 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Jian Yang
Deputy chief surgeon
Principal Investigators
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Shiqiang Yu
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital
Jian Yang
Role: STUDY_DIRECTOR
Xijing Hospital
Locations
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Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
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Other Identifiers
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XJ-20190823
Identifier Type: -
Identifier Source: org_study_id
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