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Идёт набор NCT05275088

Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

Без фазы С лечением Atrioventricular Annular Calcification Failed Prosthetic Atrioventricular Valve/ Annulus Repair

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: Prizvalve® system.
Кому может быть актуально
Состояния в реестре: Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair. 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

An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Обзор

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

Подробное описание

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Вмешательства

  • Устройство Prizvalve® system
    Transcatheter atrioventricular valve replacement

Первичные конечные точки

  • Technical success [Срок оценки: 30 days]
Вторичные конечные точки (3)
  • Procedural Success [Срок оценки: 30 days,1 year]
  • Device success [Срок оценки: 30 days,1 year]
  • All-cause mortality [Срок оценки: 30 days,1 year]

Критерии участия

1\. Inclusion criteria for patients with severe atrioventricular valve annular calcification:

  • Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed);
  • Patient with symptoms, and NYHA Functional Class≥Ⅱ;
  • 18 years and older who is not in pregnancy or lactation;
  • Life expectancy>12 months;
  • Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;
  • According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;
  • The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;
  • Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery, or with severely calcified valve annulus that cannot be operated.

2\. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair:

  • The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis;
  • The patient is symptomatic with NYHA Functional Class≥II or hemolytic anemia requiring blood transfusion (no other causes of hemolytic anemia were found after examination);
  • 18 years and older who is not in pregnancy or lactation;
  • Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;
  • According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;
  • The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;
  • Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery.

Критерии исключения

  • Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment;
  • Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
  • Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
  • Patient with hypertrophic cardiomyopathy with obstruction;
  • Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
  • Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;
  • Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;
  • Active stage of infective endocarditis or other active infection;
  • Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;
  • Patient with poor compliance and could not complete the study as required.

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

Китай · 1 центр
  • Zhongshan Hospital — Шанхай

Идентификаторы

NCT: NCT05275088 · P-valve-2021-12

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗