Actively Recruiting
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2021-06-02
508
Participants Needed
18
Research Sites
363 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
V
Venus MedTech (HangZhou) Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
CONDITIONS
Official Title
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Age between 60 and under 65 years with high surgical risk based on specific assessments
- Severe bicuspid aortic stenosis with mean gradient ≥40 mmHg
- Maximal aortic valve velocity ≥4.0 m/sec
- Aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2
- New York Heart Association classification II or higher
- Type 0 or type 1 bicuspid valve by computed tomography
- Annulus diameter between 20.0 mm and 29.0 mm
- Eligible for transfemoral TAVR
- Provided informed consent approved by ethics committee
You will not qualify if you...
- Contraindications for self-expanding bioprosthetic aortic valve placement
- Leukopenia (WBC < 3000 cells/mL), acute anemia (Hgb < 9 g/dL), or thrombocytopenia (Plt < 50,000 cells/mL)
- Active sepsis or bacterial endocarditis
- Heart attack within 30 days before treatment
- Stroke or transient ischemic attack within 90 days before procedure
- Life expectancy under 12 months due to severe diseases
- Need for emergency surgery before TAVR
- Allergies or contraindications to aspirin, heparin, bivalirudin, clopidogrel, nitinol, or contrast media
- Gastrointestinal bleeding preventing anticoagulation
- Refusal of blood transfusion
- Severe dementia affecting consent or follow-up
- Other conditions preventing protocol adherence
- Participation in another investigational drug or device study
- Hypertrophic obstructive cardiomyopathy
- Echocardiographic evidence of intracardiac masses or thrombi
- Severe mitral stenosis requiring surgery
- Indeterminate aortic valve type
- Severe aortic disease or anatomical issues precluding safe device placement
- Ascending aorta diameter over 50 mm
- High risk for TAVR complications by CT assessment
- Previous pacemaker implantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
The First affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Not Yet Recruiting
2
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
4
Xiamen University Affiliated Cardiovascular Hospital
Xiamen, Fujian, China
Not Yet Recruiting
5
Guangdong People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
6
Zhengzhou Cardiovascular Hospital
Zhengzhou, Henan, China, 450016
Not Yet Recruiting
7
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
8
Hennan Provincial Chest Hospital
Zhengzhou, Hennan, China
Not Yet Recruiting
9
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
10
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
Not Yet Recruiting
11
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
Not Yet Recruiting
12
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
13
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
14
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Not Yet Recruiting
15
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China, 030024
Not Yet Recruiting
16
tianjin Chest Hospital
Tianjing, Tianjing, China, 300222
Not Yet Recruiting
17
The Second Affiliated Hospital Zhejiang University School of Medicine.
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
18
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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