VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

Официальное название

A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis

Обзор

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Подробное описание

This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.

Вмешательства

• Устройство VitaFlow™ II Transcatheter Aortic Valve System
  VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire

Первичные конечные точки

• Rate of all-cause mortality at 12 months post implantation [Срок оценки: 12 months post implantation]

Вторичные конечные точки (10)

• Valve function-mean prosthetic valve gradient [Срок оценки: at 30 days, 6 months, and 1 year post implantation]
• Valve function- effective orifice area [Срок оценки: at 30 days, 6 months, and 1 year post implantation]
• Valve function- degree of prosthetic valve regurgitation [Срок оценки: at 30 days, 6 months, and 1 year post implantation]
• Rate of safety events according to VARC2 [Срок оценки: at 30 days, 6 months, 1 year and annually up to 5 years post implantation]
• Rate of other TAVI-related complications [Срок оценки: at 30 days, 6 months, 1 year and annually up to 5 years post implantation]
• Rate of major adverse cardiac and cerebrovascular events(MACCE) [Срок оценки: at 30 days, 6 months, 1 year and annually up to 5 years post implantation]
• Rate of device success [Срок оценки: at immediate post implantation]
• Rate of balloon pre-dilation success [Срок оценки: at immediate post implantation]
• Rate of balloon post-dilation success [Срок оценки: at immediate post implantation]
• Rate of procedure success [Срок оценки: at immediate post implantation]

Критерии участия

Критерии включения

• Age≥70 years;
• Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area<0.8cm² (or EOA index<0.5cm²/m²);
• NYHA≥II class;
• Estimated life-expectancy>12 months after implantation of the prosthetic valve;
• Anatomically suitable for the transcatheter aortic valve implantation procedure;
• The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.

Критерии исключения

• Acute myocardial infarction (MI) in last 30 days before the treatment;
• Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
• Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
• Previous implantation of heart valve at any position；
• Hemodynamic instability requiring mechanical hemodynamic support devices;
• Need for emergency surgery for any reason;
• Hypertrophic cardiomyopathy with obstruction;
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction;
• Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
• Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
• Congenital aortic valve stenosis or unicuspid aortic valve;
• Vascular diseases or anatomical condition preventing the device access;
• Active endocarditis or other active infections at the time of treatment;
• Participating in another trial and the primary endpoint is not achieved.
• Inability to comply with the clinical investigation follow-up or other requirements.

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 · 4 центра

• Fuwai Hospital — Пекин
• Zhongshan Hospital — Шанхай
• West China Hospital of Sichuan University — Чэнду
• The Second Affiliated Hospital Zhejiang University School of Medicine — Ханчжоу

Публикации

• Chen S, Zhan Z, Chen D, Jin Q, Zhang Y, Zhang X, Pan W, Zhou D, Ge J. Two-year outcomes of transcatheter aortic valve replacement with the vitaflow libertyTM system in high-surgical-risk patients with severe aortic stenosis. J Cardiothorac Surg. 2026 Jun 15. doi: 10.1186/s13019-026-04317-0. Online ahead of print. PMID 42298602

Идентификаторы

NCT: NCT04414878 · SUPERIOR-2017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗