Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

Официальное название

Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk

Обзор

The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Подробное описание

This study is a multicenter, single-arm, prospective clinical study.

Вмешательства

• Устройство Prizvalve Pro™ transcatheter aortic valve system
  Transcatheter Aortic Valve Replacement

Первичные конечные точки

• Composite endpoint event rate at 30 days [Срок оценки: 30 days after procedure]

Вторичные конечные точки (12)

• Device success rate [Срок оценки: Immediately after procedure]
• Procedural success rate [Срок оценки: Immediately after procedure]
• Delivery system and component performance evaluation [Срок оценки: Immediately after procedure]
• Valve function [Срок оценки: Immediately after procedure, 1 day of discharge, 30 days, 1 year]
• Improvement in cardiac function [Срок оценки: 1 day of discharge, 30 days, 1-5 year]
• Improvement in quality of life [Срок оценки: 30 days, 1 year]
• Incidence of all-cause mortality [Срок оценки: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year]
• Incidence of myocardial infarction [Срок оценки: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year]
• Incidence of disabling stroke [Срок оценки: 1 day of discharge, 30 days, 1-5 year]
• Incidence of permanent pacemaker implantation [Срок оценки: 1 day of discharge, 30 days, 1-5 year]
• Incidence of serious vascular and access-related complications [Срок оценки: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year]
• Incidence of serious bleeding [Срок оценки: 1 day of discharge, 30 days, 1-5 year]

Критерии участия

Критерии включения

• Age ≥ 65 years ;
• Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm², or AVA <0.5cm² /m²);
• Cardiac function NYHA ≥ II;
• Life expectancy> 12 months;
• Patients who are anatomically suitable for transcatheter aortic valve implantation;
• Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
• Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.

Критерии исключения

• Acute myocardial infarction occurred within 1 month before this treatment;
• Congenital unicuspid aortic valve;
• Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);
• Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+);
• Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
• Untreated severe coronary artery stenosis that requires revascularization;
• Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
• Patients who need emergency surgery for any reason;
• Patients with hypertrophic cardiomyopathy with obstruction;
• Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Patients with left ventricular outflow tract obstruction;
• A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
• Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
• Patients who are unable to receive anticoagulation or antiplatelet therapy;
• Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
• Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
• Active infective endocarditis or other active infections;
• Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
• The investigator judged that 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

• Shanghai NewMed Medical Co., Ltd. — Шанхай

Идентификаторы

NCT: NCT05864456 · Prizvalve Pro-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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