Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 24, 2022

Primary Completion Date

November 24, 2025

Study Completion Date

November 24, 2029

Conditions
Mitral RegurgitationDegenerative Mitral Valve Disease
Interventions
DEVICE

GeminiOne Transcatheter Valve Edge-to-Edge Repair System

The transcatheter valve clamp system consists of a valve clamp, an adjustable bend mid-tube, and a manipulated inner tube. The adjustable bend introducer catheter consists of an adjustable bend outer tube and dilator. The valve clip is composed of nickel-titanium alloy, cobalt-chromium-nickel-molybdenum-iron alloy, and polyethylene terephthalate material and contains a closure clip, gripping tab, central mechanism, braid, and suture. The adjustable bend guiding catheter is used to provide access to the transcatheter valve clamping system and to reach the designated position. The adjustable curved mid-tube and manipulated inner tube are used to enable the delivery, gripping, and release process of the valve clips within the body.

Trial Locations (1)

215025

RECRUITING

Peiga Medical Technology (Suzhou) Co., Suzhou

All Listed Sponsors
lead

Peijia Medical Technology (Suzhou) Co., Ltd.

INDUSTRY