VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
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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
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- Who runs it
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Trial code
- NCT04414865
- Record updated
- 4 June 2020
- Original description
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 world settings.Read full original descriptionShow less
A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
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 world settings.
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: Previous implantation of mechanical or bioprosthesis valve in the aortic position；; Vascular diseases or anatomical condition preventing the device access；; Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；; Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；; 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.