NCT06683729

HighLife Clarity Treatment of Severe Mitral Regurgitation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: HighLife SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system	Trans-catheter, trans-septal mitral valve replacement.

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-06-01
• Completion: 2034-06-01
• First posted: 2024-11-12
• Last updated: 2025-09-15

Regulatory

• FDA-regulated device study