NCT07086534

A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.

A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Sierra Valve LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.

Detailed description

This study is a prospective, multi-center, non-randomized clinical trial. All enrolled subjects will receive the investigational GeminiOne TEER System in a single-arm design. The trial will be conducted at up to seven clinical centers located in the United States, Canada, and Europe. The GeminiOne TEER System is intended for use in adult patients with severe symptomatic mitral regurgitation (MR) who have suitable anatomy for both device implantation and transfemoral trans-septal access for left atrial delivery. Key Inclusion Criteria: Primary MR: Patients must be deemed high-risk for surgical intervention by the site's heart team. Secondary MR: Patients must have failed to respond to optimal guideline-directed medical therapy (GDMT) for at least one month, and must also have received appropriate coronary revascularization and cardiac resynchronization therapy (CRT), if indicated. Initially, up to 15 subjects will be treated. The total duration of the study is expected to be approximately 72 months. The enrollment period will span approximately 12 months. Subjects who receive the investigational device will be followed for 60 months post-implantation.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System	The GeminiOne TEER System consists of a TEER clip implant, transcatheter delivery system and a guide sheath. The clip is made of cobalt-chromium-nickel alloy with a nickel-titanium alloy gripper, covered with a braided mesh of polyethylene terephthalate (PET) materials.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-04-30
• Completion: 2031-05-31
• First posted: 2025-07-25
• Last updated: 2025-07-25

Regulatory

• FDA-regulated device study