HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

NCT04888247 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-03

No results posted yet for this study

Summary

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

CLARITY

Trans-septal mitral valve replacement

Sponsors & Collaborators

  • HighLife SAS

    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
2021-07-01
Primary Completion
2025-12-01
Completion
2031-02-01

Countries

  • Australia
  • Belgium
  • France
  • Germany
  • Poland
  • United Kingdom

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 NCT04888247 on ClinicalTrials.gov