Actively Recruiting
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-10-03
206
Participants Needed
15
Research Sites
417 weeks
Total Duration
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AI-Summary
What this Trial Is About
To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
CONDITIONS
Official Title
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Age between 60 and 64 years with high surgical risk based on STS Risk Estimate (≥ 8%), Katz activities of Daily Living, major Organ System Dysfunction, and Procedure-Specific Impediment
- Severe bicuspid aortic stenosis with mean gradient ≥ 40 mmHg, or maximal aortic valve velocity ≥ 4.0 m/sec, or aortic valve area ≤ 1.0 cm² (or aortic valve area index ≤ 0.6 cm²/m²); if stroke volume index < 35 mL/m², low-dose dobutamine stress echocardiography is required
- New York Heart Association (NYHA) classification of II or higher
- Type 0 bicuspid aortic valve confirmed by MDCT
- Perimeter-derived annulus diameter between 20.0 mm and 26.0 mm
- Candidate for transfemoral TAVR
- Provided informed consent as approved by Institutional Review Board/Ethics Committee
You will not qualify if you...
- Contraindications for self-expanding bioprosthetic aortic valve deployment including leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL)
- Active sepsis or bacterial endocarditis
- Acute myocardial infarction within 30 days before treatment
- Stroke or transient ischemic attack within 90 days before procedure
- Life expectancy less than 12 months due to cancers, chronic liver, kidney, or end stage lung disease
- Emergent surgery required before TAVR
- Known allergies or contraindications to aspirin, heparin, bivalirudin, clopidogrel, nitinol, or contrast media
- Gastrointestinal bleeding preventing anticoagulation
- Refusal of blood transfusion
- Severe dementia preventing informed consent or study compliance
- Other medical, social, or psychological conditions precluding consent or follow-up
- Participation in another investigational drug or device study (excluding registries)
- Hypertrophic obstructive cardiomyopathy
- Intracardiac mass, thrombus, or vegetation on echocardiogram
- Severe mitral stenosis requiring surgery
- Indeterminate aortic valve type
- Significant aortic disease including severe tortuosity or aortic arch issues
- Ascending aorta diameter over 50 mm
- Aortic or iliofemoral vessel conditions precluding safe device placement
- High TAVR risk by CT corelab assessment including coronary obstruction or annular rupture
- Previous pacemaker implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Fujian Provincial Hospital, Affiliated to Fuzhou University
Fuzhou, Fujian, China
Actively Recruiting
2
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
Actively Recruiting
3
Lanzhou University First Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
4
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
5
SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University
Guangzhou, Guangdong, China
Actively Recruiting
6
Yulin First People's Hospital
Yulin, Guangxi, China, 537000
Actively Recruiting
7
Zhengzhou Seventh People's Hospital
Zhengzhou, Henan, China, 450016
Actively Recruiting
8
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
Actively Recruiting
9
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
10
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
Actively Recruiting
11
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Actively Recruiting
12
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266000
Actively Recruiting
13
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
Actively Recruiting
14
The Second Affiliated Hospital Zhejiang University School of Medicine.
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
15
Ning Bo First Hospital
Ningbo, Zhejiang, China, 315010
Actively Recruiting
Research Team
J
Jian' an Wang, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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