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

Recruitingn/aAges 70 Years - anyAllShanghai MicroPort CardioFlow Medtech Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • VitaFlow™ Transcatheter Aortic Valve System
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Where

2 sites
Ruijing Hospital,Jiaotong University School of Medicine
Shanghai, China
Zhongshan Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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