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)
Facility
City
Region
Status
Ruijing Hospital,Jiaotong University School of Medicine
Shanghai
Shanghai Municipality
Not Yet Recruiting
Zhongshan Hospital
Shanghai
Shanghai Municipality
Recruiting
More Shanghai MicroPort CardioFlow Medtech Co., Ltd. trials in China
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.
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