Actively Recruiting
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
Led by Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Updated on 2020-06-04
100
Participants Needed
2
Research Sites
400 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
CONDITIONS
Official Title
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6570 years
- Symptomatic, calcified, severe, degenerative native aortic valve stenosis with peak velocity 654.0m/s, or mean transvalvular gradient 6540mmHg, or aortic valve area <0.8cm�b2 (or EOA index <0.5cm�b2/m�b2)
- Not suitable for surgical aortic valve replacement (SAVR)
- Willing to sign informed consent and agree to scheduled follow-up
You will not qualify if you...
- Aortic root anatomy not suitable for transcatheter aortic valve implantation
- Vascular diseases or anatomical conditions preventing device access
- Previous implantation of mechanical or bioprosthesis valve in the aortic position
- Known hypersensitivity or contraindication to anticoagulation/antiplatelet regimens, nitinol, contrast media, or related elements
- Ongoing sepsis or active endocarditis
- Estimated life expectancy less than 12 months
- Participating in another trial without achieving primary endpoint
- Unable to comply with follow-up or other study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ruijing Hospital，Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Z
Zhujun Cai, PhD
CONTACT
J
Jie Bi
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
1
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