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Recruiting Observational

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

NCT04414865 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2020-04-26
Last updated
2020-06-04

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

VitaFlow™ Transcatheter Aortic Valve System

VitaFlow™ Transcatheter Aortic Valve System: VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set

Study summary

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.

Eligibility

Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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 for surgical aortic valve replacement (SAVR); * The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement. Exclusion Criteria: * Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve; * Vascular diseases or anatomical condition preventing the device access; * Previous implantation of mechanical or bioprosthesis valve in the aortic position; * Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements; * Ongoing sepsis, including active endocarditis; * Estimated Life expectancy\< 12 months; * Participating in another trial and the primary endpoint is not achieved. * Inability to comply with the clinical investigation follow-up or other requirements.

Primary outcome measure(s)

  • Rate of all-cause mortality at 12 months post implantation — 12 months post implantation
    Rate of all-cause mortality including cardiovascular and non-cardiovascular death

Trial sites (2)

FacilityCityRegionStatus
Ruijing Hospital,Jiaotong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Zhongshan Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04414865 on ClinicalTrials.gov ↗ ← All trials in China