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

Part of paid clinical trials in Thousand Oaks, California.

Sponsor
Sierra Valve LLC
Study ID
NCT07086534
Status
Recruiting
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Conditions

  • Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System — DEVICE
    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.

Study Details

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

Key Dates

Start date
Mar 26, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects receiving the treatment of GeminiOne TEER system

Primary Outcome Measure

Safety: Absence of device or procedure related major adverse events at 30 days [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Los Robles Regional Medical CentreThousand OaksCalifornia91360

Find similar trials in Thousand Oaks, CA

By research site
Los Robles Regional Medical Centre· Thousand Oaks, CA

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