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Набор скоро начнётся NCT07243158

Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

Без фазы С лечением Mitral Regurgitation Functional

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: DragonFly System, Drug.
Кому может быть актуально
Состояния в реестре: Mitral Regurgitation Functional. 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
Китай
Следующий шаг
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Официальное название

A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the DragonFly Transcatheter Mitral Valve Clip System in the Treatment of Moderate-to-Severe or Severe Functional Mitral Regurgitation (FMR)

Обзор

To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.

Подробное описание

This study is a prospective, multicenter, randomized controlled design. Patients are chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly™ Transcatheter Mitral Valve Clip System . According to the investigator's discretion, all subjects in the treatment group will continue to receive maximally tolerated guideline-directed medical therapy (GDMT). Subjects in the control group will also continue maximally tolerated GDMT as determined by the investigator. After completing the 12-month follow-up, crossover to the treatment group will be permitted.

All subjects were followed up before discharge (excluding the control group), and 30 days, 6 months, 12 months, and 24 months after treatment. Subjects in the experimental group and those who crossed over to the experimental group underwent extended clinical follow-up for 3, 4, and 5 years.

Вмешательства

  • Устройство DragonFly System
    This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
  • Препарат Drug
    This group will continue to be managed on medical therapy, per physician discretion

Первичные конечные точки

  • Clinical success at 12 months after the procedure [Срок оценки: 12 months]
Вторичные конечные точки (8)
  • Mitral regurgitation severity [Срок оценки: 30 days, 6 months, 12 months]
  • Recurrent heart failure (HF) hospitalizations [Срок оценки: 30 days, 6 months, 12 months]
  • NYHA Class [Срок оценки: 30 days, 6 months, and 12 months]
  • Change in 6 minutes walk test distance [Срок оценки: 12 months]
  • Quality of life improvement [Срок оценки: 12 months]
  • Left Ventricular End Diastolic Volume (LVEDV) [Срок оценки: 12 months]
  • Acute procedural success（only for experimental group） [Срок оценки: Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory]
  • Acute device success（only for experimental group） [Срок оценки: Immediately after procedure]

Критерии участия

Критерии включения

1\) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy

  • Transseptal catheterization and femoral vein access is determined to be feasible.
  • The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.

Критерии исключения

1\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2）Echocardiography revealed severe restriction of leaflet motion due to tethering.

3\) The presence of other severe heart valve disease requiring surgical intervention.

  • Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  • In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07243158 · DragonFly-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗