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NOT YET RECRUITING
NCT06683729
NA

HighLife Clarity Treatment of Severe Mitral Regurgitation

Sponsor: HighLife SAS

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-12-30

Completion Date

2034-06

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

DEVICE

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

Trans-catheter, trans-septal mitral valve replacement.