VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
Recruiting now
Conditions studied: Aortic Valve Stenosis
In brief
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.
Key facts
- Study ID
- NCT04414865
- Run by
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- People needed
- 100
- Starts
- 2020-04-26
- Expected to finish
- 2027-12-30
- Last updated by the study team
- 2020-06-04
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zhongshan Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Ruijing Hospital，Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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