Status:
RECRUITING
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
Lead Sponsor:
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Conditions:
Aortic Stenosis
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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 s...
Detailed Description
This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic V...
Eligibility Criteria
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;
- 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.
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04414878
Start Date
January 31 2018
End Date
January 31 2027
Last Update
June 4 2020
Active Locations (4)
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1
Fuwai Hospital
Beijing, Beijing Municipality, China
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
3
West China Hospital of Sichuan University
Chengdu, Sichuan, China
4
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China