Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

Официальное название

Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves

Обзор

The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.

Подробное описание

Prospective, single arm, multicenter study

Вмешательства

• Устройство Prizvalve® system Transcatheter valve-in-valve replacement
  Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.

Первичные конечные точки

• All-cause mortality [Срок оценки: At 30 days]

Вторичные конечные точки (12)

• Device success [Срок оценки: immediate post-surgical]
• Procedural success [Срок оценки: immediate post-surgical]
• All-cause mortality [Срок оценки: At 6 months, 1 year]
• The incidence of rehospitalization [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of myocardial infarction [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of stroke [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of bleeding [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of acute kidney injury [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of permanent pacemaker implantation [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of vascular and access-related complications [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of procedure-related complications [Срок оценки: At 30 days, 6 months, 1 year]
• The incidence of valve dysfunction [Срок оценки: At 30 days, 6 months, 1 year]

Критерии участия

Критерии включения

Subjects must meet all of the following inclusion criteria to be eligible for participation:

• Age≥18 years old;
• Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
• NYHA Function Class≥ II;
• Patient who is anatomically suitable for the implantation of the Prizvalve®;
• According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;
• Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.

Критерии исключения

• Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；
• Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；
• Anatomical features deemed unsuitable for transcatheter implantation.
• Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；
• Acute myocardial infarction within 30 days prior to enrollment；
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation；
• Active infective endocarditis or any other active infection；
• Severe right ventricular dysfunction or severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20 %；
• Inability to tolerate anticoagulant or antiplatelet therapy；
• Cerebrovascular accident within 3 months prior to enrollment, excluding transient ischemic attack；
• Refusal to undergo emergency cardiac surgery under any circumstances；
• Participation in another drug or device clinical trial that has not yet reached its primary endpoint as of the time of enrollment；
• Investigator-assessed poor compliance that would preclude adherence to protocol requirements；

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical Univer — Сиань

Идентификаторы

NCT: NCT07122050 · Prizvalve-VIV-202504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗