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RecruitingNot ApplicableNCT06038838

Feasibility Study of the Tioga TMVR System

Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation

Sponsor

Tioga Cardiovascular, Inc.

Enrollment

30 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Mitral Regurgitation

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Tioga TMVR System for people with mitral regurgitation. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETioga 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.

Locations(5)

Incor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, Brazil

Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)

Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Vilnius Univ. Hospital

Vilnius, Lithuania

Sanatorio Italiano

Asunción, Paraguay

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NCT06038838

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