No phaseNot yet recruiting
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
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)
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd. (Industry)
- Enrolment
- 152 planned
- Conditions
- Degenerative Mitral Regurgitation
- Interventions
- Microport CardioFlow Mitral Valve Replacement System
- Ages
- older adults
- Registry
- NCT07857343
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Rate of cumulative all-cause mortality at 12 months post-procedure
History
Study completion expected
Primary completion expected
Expected to start
Registered