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HighLife Clarity Treatment of Severe Mitral Regurgitation

NCT06683729 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-09-15

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment with approved transcatheter repair (sub-optimal results to complex or prohibitive edge-to-edge repair) or surgical mitral valve intervention according to guidelines.

Conditions

  • Mitral Valve (MV) Regurgitation

Interventions

DEVICE

Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system

Trans-catheter, 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
2025-12-30
Primary Completion
2028-06-30
Completion
2034-06-30
FDA Device
Yes

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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 NCT06683729 on ClinicalTrials.gov