NCT07320274尚未招募不适用
ArcFlex Sheath in TAVR Trial(Arc-FIT)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年3月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- surgical instruments
研究概览
简要总结
TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Judged by a professional cardiologist to require TAVR surgery
- •NYHA ≥ II grade
- •Evaluated by the cardiac team, the peripheral vascular approach is suitable for performing the surgery via the femoral route
- •Expected lifespan is greater than 1 year (5) Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.
排除标准
- •Presence of other valvular diseases requiring concurrent intervention.
- •Anatomical characteristics unsuitable for transcatheter valve implantation.
- •Severe mitral stenosis due to organic causes requiring surgical valve replacement or repair.
- •Hypertrophic obstructive cardiomyopathy (unexplained myocardial hypertrophy >1.5 cm).
- •Acute myocardial infarction within the past 30 days.
- •Intracardiac mass, thrombus, or vegetation indicated by echocardiography.
- •Active infective endocarditis or any other active infection.
- •Intolerance to tolerate anticoagulant or antiplatelet therapy.
- •Coagulopathy or refusal to receive blood transfusion therapy.
- •Known allergy to device materials or contrast agents.
- •Acute peptic ulcer or gastrointestinal bleeding within the past 3 months.
- •Stroke or transient ischemic attack (TIA) within the past 3 months.
- •Requirement for emergency surgical treatment for any reason.
- •Expected life expectancy of less than 12 months due to non-cardiac causes.
- •Severe disabling dementia or inability to perform activities of daily living.
- •Participation in other clinical trials of drugs or medical devices prior to enrollment and not yet reached the primary endpoint of that study.
结局指标
主要结局
surgical instruments
时间窗: 24 hours
The success rate of immediate surgical instruments
次要结局
- 30-day mortality rate(30days)
- One-year mortality rate(1 year)
研究者
Xiao-dong Zhuang
Professor
Sun Yat-sen University
研究点 (1)
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