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

NCT07086534 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Conditions

  • Mitral Regurgitation

Interventions

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.

Sponsors & Collaborators

  • Sierra Valve LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2027-04-30
Completion
2031-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086534 on ClinicalTrials.gov