Back to resultsMitralStitch Mitral Valve Repair System for Mitral Regurgitation
Primary Purpose
Mitral Regurgitation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MitralStitch
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation
Eligibility Criteria
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.
Sites / Locations
- Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MitralStitch repair system
Arm Description
Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The success of device
The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully.
The success rate of operation
Mitral regurgitation was less than moderate before discharge.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04061837
Brief Title
MitralStitch Mitral Valve Repair System for Mitral Regurgitation
Official Title
To Evaluate the Effectiveness and Safety of MitralStitch Mitral Valve Repair System - a Clinical Application of New Technology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MitralStitch repair system
Arm Type
Experimental
Arm Description
Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd
Intervention Type
Device
Intervention Name(s)
MitralStitch
Intervention Description
With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System
Primary Outcome Measure Information:
Title
The occurrence rate of major adverse event after 30 days of the intervention
Description
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.
Time Frame
30days
Secondary Outcome Measure Information:
Title
The success of device
Description
The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully.
Time Frame
Immediately after repair
Title
The success rate of operation
Description
Mitral regurgitation was less than moderate before discharge.
Time Frame
Before discharge, an average of 7 days
Title
Incidence of major adverse events after device implantation
Description
There were no major adverse events associated with device or operation within 12 months of device implantation.
Time Frame
12months
Title
The classification of mitral regurgitation
Description
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.
Time Frame
1/6/12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiqiang Yu
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian Yang
Organizational Affiliation
Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MitralStitch Mitral Valve Repair System for Mitral Regurgitation
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