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NOT YET RECRUITING
NCT07857343
NA

CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation

Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative mitral regurgitation and to provide the clinical evidence for product registration in China or other countries

Official title: A Prospective, Multicenter, Single-arm Clinical Investigation for the Evaluation of Safety and Effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement System in the Treatment of Moderate to Severe or Severe Symptomatic Mitral Regurgitation(CF-TMVR)

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2026-12-01

Completion Date

2035-01-01

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DEVICE

Microport CardioFlow Mitral Valve Replacement System

Patients will undergo transcatheter mitral valve replacement using Microport CardioFlow Mitral Valve Replacement System. The device is delivered via a transapical approach under the guidance of medical imaging equipment; the valve product loaded within the delivery system is advanced to the mitral annulus and released, thereby replacing the native mitral valve with pathological changes in function or anatomy.

Locations (3)

Cardiology

Beijing, China

Cardiology

Kunming, China

Cardiology

Zhengzhou, China