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Feasibility Study of the Tioga TMVR System

NCT06038838 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-12

No results posted yet for this study

Summary

The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\>=3+)

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

Tioga TMVR System

A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.

Sponsors & Collaborators

  • Tioga Cardiovascular, Inc.

    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
2024-04-01
Primary Completion
2026-07-01
Completion
2028-07-01
FDA Device
Yes

Countries

  • Brazil
  • Georgia
  • Lithuania
  • Paraguay

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 NCT06038838 on ClinicalTrials.gov