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Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

NCT04029363 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-15

No results posted yet for this study

Summary

to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

HighLife Transcatheter Mitral Valve Replacement

Transcatheter Mitral Valve Replacement

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • 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
2019-05-28
Primary Completion
2026-12-15
Completion
2031-12-15

Countries

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

Study Locations

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Entities

Companies

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 NCT04029363 on ClinicalTrials.gov