MitralStitch Mitral Valve Repair System for Mitral Regurgitation

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

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.

Study Overview

• Status: Unknown
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: MitralStitch

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MitralStitch repair system; Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Medtech Co., Ltd	Device: MitralStitch; With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Shiqiang Yu, Xijing Hospital; Study Director: Jian Yang, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2019
• Primary Completion (ANTICIPATED): October 31, 2020
• Study Completion (ANTICIPATED): October 31, 2021

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 18, 2019
• First Posted (ACTUAL): August 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: XJ-20190823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No