Actively Recruiting
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
Led by Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Updated on 2020-06-04
145
Participants Needed
4
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Fuwai Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
3
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
4
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
B
Bi Jie
CONTACT
Z
Zhujun Cai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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