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Recruiting NCT06038838

Feasibility Study of the Tioga TMVR System

No phase Interventional Mitral Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tioga TMVR System.
Who it may be relevant to
Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, Georgia, Lithuania, Paraguay
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

The Tioga TMVR Feasibility Study is a prospective, single-arm, multi-center study with a planned enrollment of up to 30 patients. The Tioga TMVR System is designed to percutaneously replace a patient's diseased native mitral valve with a bioprosthetic valve. The investigational device is intended for transseptal replacement of the mitral valve in patients with symptomatic MR (MR\>=3+).

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.

Primary outcome measures

  • Primary Safety Endpoint [Time frame: From index procedure (Day 0) to 30 days post-procedure]
  • Primary Performance Endpoint [Time frame: At completion of index procedure (Day 0)]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older
  • Symptomatic, moderate to severe (3+) or severe (4+) MR
  • NYHA Functional Classification ≥ II
  • Heart team concurs that the subject is non-ideal for surgical intervention or other available treatment options (e.g., TEER)
  • The subject or the subject's legal representative has been informed of the nature of the study, has agreed to return for post-procedure follow-up visits, and has provided informed consent

Exclusion criteria

  • LVEF < 30%
  • LVEDD > 70 mm
  • Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, MAC) unsuitable for the Tioga TMVR System
  • Severe aortic valve stenosis or regurgitation
  • Severe right ventricular dysfunction or severe tricuspid valve disease
  • Evidence of intracardiac thrombus, vegetation, or mass
  • Prior mitral valve intervention
  • Prior prosthetic heart valve in any position
  • Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to enrollment
  • Any carotid surgery within 30 days prior to enrollment
  • Any open cardiac or vascular surgery (other than carotid surgery) within 90 days prior to enrolment
  • Myocardial infarction within 30 days prior to enrollment
  • Cardiac resynchronization therapy (CRT) device implanted within 30 days of enrollment
  • History of endocarditis within 6 months prior to enrollment or evidence of active systemic infection or sepsis.
  • Planned cardiovascular procedure within 30 days of enrolment
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days of enrollment
  • Active peptic ulcer or active GI bleeding within 90 days of enrollment
  • Cardiogenic shock or hemodynamic instability requiring inotropic support or mechanical heart assistance
  • Pulmonary arterial hypertension with fixed PASP > 70mmHg or PVR > 5WU that cannot be reduced to less than 5WU with vasodilator therapy
  • Severe chronic obstructive pulmonary Disease (COPD) or airways disease requiring continuous home oxygen
  • Renal insufficiency (eGFR <20 mL/min) or ESRD on dialysis
  • Life expectancy < 12 months
  • Subject is on the waiting list for a transplant or has had a prior heart transplant
  • Child class C cirrhosis
  • Blood dycrasias as defined by acute anemia with Hb < 9, platelets < 75K, WBC < 0.5
  • Female subjects who is breast feeding or pregnant or planning to become pregnant within the study period.
  • Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution) or hypersensitivity to nickel or titanium
  • Inability to tolerate anticoagulation or antiplatelet therapies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Georgia · 2 centers
  • Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore) — Tbilisi
  • Tbilisi Heart and Vascular Clinic — Tbilisi
Brazil · 1 center
  • Incor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo
Lithuania · 1 center
  • Vilnius Univ. Hospital — Vilnius
Paraguay · 1 center
  • Sanatorio Italiano — Asunción

Identifiers

NCT: NCT06038838 · CP-03218

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗