Status:
RECRUITING
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
Lead Sponsor:
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
70+ years
Brief Summary
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Age≥70 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 area\<0.8cm² (or EOA index\<0.5cm²/m²);
- 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
- 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.
Key Trial Info
Start Date :
April 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04414865
Start Date
April 26 2020
End Date
December 30 2027
Last Update
June 4 2020
Active Locations (2)
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1
Ruijing Hospital，Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China