MitralStitch Mitral Valve Repair System for Mitral Regurgitation

Not Applicable

• Conditions: Mitral Regurgitation
• Interventions: Device: MitralStitch

• Registration Number: NCT04061837
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-18
• Study First Posted: 2019-08-20
• Last Update Submitted: 2019-08-22
• Study Start: 2019-08-23
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. The age of patient is ≥18yrs;
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

1. Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MitralStitch repair system	MitralStitch	Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd

Primary Outcome Measures

Name	Time	Method
The occurrence rate of major adverse event after 30 days of the intervention	30days	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

Name	Time	Method
The success rate of operation	Before discharge, an average of 7 days	Mitral regurgitation was less than moderate before discharge.
Incidence of major adverse events after device implantation	12months	There were no major adverse events associated with device or operation within 12 months of device implantation.
The success of device	Immediately after repair	The MitralStitch mitral valve repair system reaches the mitral valve and implant the chord and withdraw the system successfully.
The classification of mitral regurgitation	1/6/12 months	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.

Trial Locations

Locations (1)

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China