MitralStitch Mitral Valve Repair System for Mitral Regurgitation

NCT04061837 | Unknown

• 1 other identifier: XJ-20190823
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The success of device

  Immediately after repair

• The success rate of operation

  Before discharge, an average of 7 days

• Incidence of major adverse events after device implantation

  12months

• The classification of mitral regurgitation

  1/6/12 months

Study Arms (1)

MitralStitch repair system

EXPERIMENTAL

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

Device: MitralStitch

Interventions

MitralStitch DEVICE

With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System

MitralStitch repair system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Shiqiang Yu

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

• Jian Yang

  Xijing Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief surgeon

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 20, 2019
• Study Start: August 23, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)