Actively Recruiting
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Led by Xijing Hospital · Updated on 2025-06-19
450
Participants Needed
4
Research Sites
322 weeks
Total Duration
On this page
Sponsors
X
Xijing Hospital
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 70 years at time of consent
- Severe aortic stenosis diagnosed by echocardiography with specific criteria for symptomatic or asymptomatic patients
- Tricuspid or Type-1 bicuspid aortic valve anatomy confirmed by CT scan
- Agreement by patient and physician to attend all post-procedure follow-up visits
- Adequate iliofemoral access with acceptable vessel condition for device implantation
- Informed consent provided as approved by Institutional Review Board
You will not qualify if you...
- No valve calcification or challenging calcification as decided by physicians
- Congenital unicuspid valve, Type-0 or Type-2 bicuspid valve, or quadricuspid valve
- Severe vascular disease preventing transfemoral TAVR
- Acute myocardial infarction within past 30 days
- Need for open heart surgery due to other valve or heart conditions
- Ascending aorta diameter 45 mm or greater in bicuspid valve patients, or 50 mm or greater in tricuspid valve patients
- Mechanical or bioprosthetic heart valve in any position
- Hemodynamic or respiratory instability needing support within 30 days
- Emergency surgical or interventional procedures within 30 days
- Hypertrophic cardiomyopathy
- Left ventricular ejection fraction below 30%
- Presence of ventricular mass, thrombus, or vegetation on imaging
- Allergies or inability to tolerate heparin, contrast agents, warfarin, aspirin, or clopidogrel
- Stroke or transient ischemic attack within past 180 days
- Renal replacement therapy at screening
- Severe lung disease or current home oxygen use
- Life expectancy less than 24 months
- Participation in other investigational drug or device studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
Xi'an, Shaanxi, China, 710032
Actively Recruiting
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
3
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Not Yet Recruiting
4
Shanghai Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Jian Yang, MD, PhD
CONTACT
M
Meng en Zhai, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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