VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study

Recruiting Observational Study
Aortic Valve Stenosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
70 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age≥70 years; * Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area\<0.8cm² (or EOA index\<0.5cm²/m²); * The patients considered to be not suitable fo…
Contacts

Zhujun Cai, PhD

(86)(21)38954600

zjcai@micoport.com

CONTACT

Jie Bi

(86)(21)38954600

jbi@micoport.com

CONTACT