Feasibility Study of the Tioga TMVR System

Официальное название

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

Обзор

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

Подробное описание

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+).

Вмешательства

• Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Грузия · 2 центра

• Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore) — Tbilisi
• Tbilisi Heart and Vascular Clinic — Tbilisi

Бразилия · 1 центр

• Incor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo

Литва · 1 центр

• Vilnius Univ. Hospital — Vilnius

Paraguay · 1 центр

• Sanatorio Italiano — Asunción

Идентификаторы

NCT: NCT06038838 · CP-03218

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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