NCT04343313

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Half Moon Medical · Industry
• Sex: All
• Age: 21 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.

Conditions

• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Half Moon TMVr System	The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.

Timeline

• Start date: 2020-12-08
• Primary completion: 2024-12-31
• Completion: 2029-12-31
• First posted: 2020-04-13
• Last updated: 2024-01-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study