VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Trial code
- NCT04414878
- Record updated
- 4 June 2020
- Original description
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.Read full original descriptionShow less
A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Inclusion: Age≥70 years; Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area<0.8cm² (or EOA index<0.5cm²/m²); NYHA≥II class; Estimated life-expectancy>12 months after implantation of the prosthetic valve; Anatomically suitable for the transcatheter aortic valve implantation procedure; The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; 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: Acute myocardial infarction (MI) in last 30 days before the treatment; Previous implantation of heart valve at any position；; Need for emergency surgery for any reason; Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months; Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements; Vascular diseases or anatomical condition preventing the device access; Active endocarditis or other active infections at the time of treatment; Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction; Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；; Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation; Hemodynamic instability requiring mechanical hemodynamic support devices; Hypertrophic cardiomyopathy with obstruction; Congenital aortic valve stenosis or unicuspid aortic valve; Participating in another trial and the primary endpoint is not achieved; Inability to comply with the clinical investigation follow-up or other requirements.