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An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Без фазы С лечением Mitral Regurgitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcatheter Mitral Valve Replacement.
Кому может быть актуально
Состояния в реестре: Mitral Regurgitation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.

Подробное описание

Protocol Title:

An Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System

Protocol # HL-2019-01, ver. 5.0

Phase: United States Early Feasibility Study

Investigational Devices:

The HighLife 28mm Trans-Septal Mitral Valve and its delivery systems. These devices compose the HighLife Trans-septal Mitral Valve Replacement (TSMVR) System.

* Size 28 mm TMV (CLARITY valve) * Size 28 mm TMV-L (CLARITY large annulus valve/ LAV)

Intended Use: The HighLife TSMVR system is intended for the trans-septal access percutaneous mitral valve replacement in patients suffering from symptomatic moderate-severe or severe mitral regurgitation (MR) due to primary (degenerative) or secondary (functional) abnormality of the mitral valve.

Device Description:

The HighLife TSMVR system is composed of a Trans-Septal (Mitral Valve (TSMV), a sub-annular implant (SAI), and their delivery systems and accessories. The TMV is a 28 mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.

Design: A single arm, prospective, multicenter, non-randomized and open-labelled study.

Purpose: The purpose of the study is to evaluate the feasibility, safety and performance of the HighLife 28mm Trans-septal Mitral Valve Replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment or deemed more appropriate to receive transcatheter mitral valve replacement than to receive conventional mitral valve surgery according to the local multidisciplinary Heart Team.

Objectives: Primary objectives are to evaluate the feasibility, safety and performance of the HighLife 28mm TSMVR system at 30 days. Secondary objectives are to evaluate long term safety and performance of the HighLife TSMVR system.

Вмешательства

  • Устройство Transcatheter Mitral Valve Replacement
    Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system

Первичные конечные точки

  • Freedom of major adverse events [Срок оценки: at 30 days post procedure]
  • Continued intended performance of the HighLife™ bioprosthesis [Срок оценки: at 30 days post procedure]
Вторичные конечные точки (1)
  • Technical success [Срок оценки: immediately after procedure]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Severe mitral regurgitation
  • New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
  • Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
  • Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
  • Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
  • Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE

Main Exclusion Criteria:

  • Mitral stenosis
  • Rheumatic valve disease
  • Severe calcifications of the mitral annulus and/or mitral leaflets
  • Prior surgical or interventional treatment of the mitral valve
  • Unsuitable anatomy for the transapical access
  • Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
  • Untreated clinically significant coronary artery disease requiring revascularization
  • LVEF < 30%
  • LVEDD > 70mm
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • Hypertrophic Obstructive Cardiomyopathy (HOCM)
  • Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure

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

США · 10 центров
  • Tucson Medical Center — Tucson
  • Los Robles Regional Medical Center — Los Angeles
  • Piedmont Heart — Atlanta
  • Brigham and Women's Hospital — Boston
  • Minneapolis Heart — Minneapolis
  • Montefiore Medical Center — New York
  • University of Pennsylvania — Philadelphia
  • Medical University of South Carolina — Charleston
  • … и ещё 2 центра

Идентификаторы

NCT: NCT04029337 · HL-2019-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗