Overview
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.
Description
This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.
Eligibility
Inclusion Criteria:
- Age70 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 area0.8cm (or EOA index0.5cm/m);
- 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.