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Safety and Performance Study of the MitralStitch Repair System.

NCT04080362 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-02-28

No results posted yet for this study

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

Interventions

DEVICE

MitralStitch

With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial neochordae or ege-to-ege repair using MitralStitch System

Sponsors & Collaborators

  • Hangzhou Valgen Medtech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Shengshou Hu · Chinese Academy of Medical Science, Fuwai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-05
Primary Completion
2021-06-01
Completion
2022-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080362 on ClinicalTrials.gov