VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
100 participants
Apr 26, 2020
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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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Interventions
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
Locations(2)
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NCT04414865