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Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

Key facts

Where
Beijing, Chengdu, Shanghai, and Xi'an, ChinaSee the 4 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 50 and 70 years old?

Source: NCT06830499, who can take part

Where in China

  • Fuwai Hospital Chinese Academy of Medical SciencesBeijing, ChinaContact: Xiangbin Pan, MD, PhDNot yet recruiting
  • West China Hospital，Sichuan UniversityChengdu, ChinaContact: Yingqiang Guo, MD, PhDNot yet recruiting
  • Shanghai Zhongshan Hospital, Fudan UniversityShanghai, ChinaContact: Lai Wei, MD, PhDTaking people
  • Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical UniversityXi'an, ChinaContact: Jian Yang, MD, PhDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Xijing Hospital
Trial code
NCT06830499
Record updated
27 May 2026
Original description
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational studyRead full original descriptionShow less

Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study

Inclusion: Subjects must meet ALL of the following inclusion criteria to be eligible for participation:; 50 years of age or older but ≤70 years old at time of consent; Severe AS, defined as follows:; 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%; Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by 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 been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion: Emergency interventional/surgical procedures within 30 days of the valve implant procedure; Renal replacement therapy at the time of screening; Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen; 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; Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia; Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease); Aortic disease: a. bicuspid aortic valve with an ascending aorta diameter ≥ 45mm b. tricuspid aortic valve with an ascending aorta diameter ≥ 50mm; Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit; Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation; Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel; Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure; Ventricular dysfunction with LVEF < 30%; Subjects are NOT eligible for participation if they meet ANY of the following exclusion criteria:; Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases); Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve; Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR; Pre-existing mechanical or bioprosthetic valve in any position; Hypertrophic cardiomyopathy with or without obstruction; Estimated life expectancy < 24 months.

ClinicalTrials.gov NCT06830499