NCT07450196尚未招募不适用
A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China
Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2026年4月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- The composite of all-cause mortality, stroke, or rehospitalization
研究概览
简要总结
In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR.
- •Severe AS, defined as follows:
- •a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
- •Type-0 bicuspid aortic valve anatomy confirmed by multi-detector computed tomography (MDCT).
- •The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- •Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.
- •The study patient has provided written informed consent.
排除标准
- •Challenging calcification based on physician's experience and discretion
- •Aortic valve is a congenital unicuspid valve, congenital Type-1 or Type-2 bicuspid valve, tricuspid or quadricuspid valve
- •Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR
- •Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease)
- •Pre-existing mechanical or bioprosthetic valve in any position
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit
- •Emergency interventional/surgical procedures within 30 days of the valve implant procedure
- •Hypertrophic cardiomyopathy with obstruction
- •Ventricular dysfunction with LVEF < 30%
- •Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation
- •Renal replacement therapy at the time of screening
- •Estimated life expectancy < 12 months
- •Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.
研究组 & 干预措施
patients with Type-0 bicuspid aortic stenosis
patients with severe, calcific aortic stenosis and with Type-0 bicuspid anatomy confirmed by MDCT.
干预措施: Transcatheter Aortic Valve Replacement (Device)
结局指标
主要结局
The composite of all-cause mortality, stroke, or rehospitalization
时间窗: At 1 year after procedure
The composite of all-cause mortality, stroke, or rehospitalization
次要结局
- Major or life-threatening bleeding(At 30 days, 1year)
- Myocardial infarction(At 30 days, 1year)
- Acute kidney injury stage 2 or 3(At 30 days, 1year)
- Need for a permanent pacemaker(At 30 days, 1year)
- New onset atrial fibrillation(At 30 days, 1year)
- Valve endocarditis(At 30 days, 1year)
- Valve thrombosis(At 30 days, 1year)
- New York Heart Association class(At 30 days, 1year)
- Patient-prosthesis mismatch(At 30 days, 1year)
- Index hospitalization days(At discharge (assessed up to 30 days))
- The composite of all-cause mortality, stroke, or rehospitalization(At 30 days after procedure)
- The composite of device success(At 30 days after procedure)
- Annular rupture(At discharge(assessed up to 30 days))
- Paravalvular leakage(At discharge (assessed up to 30 days) , 30 days, 1year)
- Major vascular complication(At 30 days, 1year)
- Technical success(At exit from procedure room)
- Procedural success(At 30 days)
- Mortality (all cause & cardiovascular)(At 30 days,1year)
- Stroke (disabling and nondisabling)(At 30 days, 1year)
- Rehospitalization (procedure, valve and heart failure related)(At 30 days, 1year)
- Health status as evaluated by Quality of Life questionnaires - KCCQ(At baseline, 30 days, 1year)
研究者
Pan Xiangbin
Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (1)
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