Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis

Обзор

This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Вмешательства

• Устройство RENATUS® TAVR
  RENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR

Первичные конечные точки

• Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths) [Срок оценки: 1 year post-procedure]

Вторичные конечные точки (3)

• Procedural success rate [Срок оценки: Perioperative]
• Device success rate; [Срок оценки: Perioperative]
• All-cause mortality at 1, 3, 5, and 10 years [Срок оценки: 1, 3, 5, and 10 years]

Критерии участия

Критерии включения

• Patients deemed eligible for TAVR by the treating physician, including those at high, intermediate, or low surgical risk, with a calculated Society of Thoracic Surgeons (STS) risk score;
• Symptomatic patients with severe aortic stenosis, defined by echocardiography as having at least one of the following:

• Mean transvalvular pressure gradient ≥40 mmHg (1 mmHg = 0.133 kPa),
• Peak aortic jet velocity ≥4.0 m/s,
• Aortic valve area <1.0 cm², or Indexed effective orifice area <0.6 cm²/m²;
• Patients who understand the purpose of the trial, voluntarily agree to participate, provide written informed consent, and are willing to undergo required examinations and clinical follow-up.

Критерии исключения

• Patients with a life expectancy of ≤1 year following prosthetic valve implantation;
• Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;
• Patients with minimal or no calcification of the aortic annulus;
• Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;
• Patients with multivalvular disease (severe stenosis and/or regurgitation);
• Patients with hematologic cachexia, including leukopenia (WBC <3×10⁹/L), acute anemia (Hb <90 g/L), thrombocytopenia (PLT <50×10⁹/L), bleeding diathesis, or coagulopathy;
• Patients with untreated coronary artery disease requiring revascularization;
• Patients with obstructive hypertrophic cardiomyopathy;
• Patients with severe left ventricular dysfunction (LVEF <20%);
• Patients with severe right ventricular dysfunction;
• Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;
• Patients unable to tolerate anticoagulant or antiplatelet therapy;
• Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months;
• Patients with decompensated renal insufficiency;
• Patients with active infective endocarditis or other active infections;
• Patients with untreated conduction system disease requiring pacemaker implantation;
• Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;
• Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.

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

• Beijing Anzhen Hospital, Capital Medical University — Пекин
• Beijing Chaoyang Hospital, Capital Medical University — Пекин
• Fu Wai Hospital, Chinese Academy of Medical Sciences — Пекин
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07414342 · KS2026002 · Z251100004625015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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