VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
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
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
145 participants
Jan 31, 2018
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria15
- Acute myocardial infarction (MI) in last 30 days before the treatment;
- 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;
- Previous implantation of heart valve at any position；
- Hemodynamic instability requiring mechanical hemodynamic support devices;
- Need for emergency surgery for any reason;
- Hypertrophic cardiomyopathy with obstruction;
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction;
- 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.
- Congenital aortic valve stenosis or unicuspid aortic valve;
- Vascular diseases or anatomical condition preventing the device access;
- Active endocarditis or other active infections at the time of treatment;
- 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™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04414878