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.
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…
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