MedTrace Logo

Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China

NCT05610566 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-11-09

No results posted yet for this study

Summary

To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System

The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Peijia Medical Technology (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-06
Primary Completion
2025-07-06
Completion
2029-07-06

Countries

  • China

Study Locations

More Related Trials

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 NCT05610566 on ClinicalTrials.gov