NCT04414865 VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
| NCT ID | NCT04414865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai MicroPort CardioFlow Medtech Co., Ltd. |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-04-26 |
| Primary Completion | 2021-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-04-26 with a primary completion date of 2021-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 world settings.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04414865 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04414865 currently recruiting?
Yes, NCT04414865 is actively recruiting participants. Contact the research team at zjcai@micoport.com for enrollment information.
Where is the NCT04414865 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT04414865 clinical trial?
NCT04414865 is sponsored by Shanghai MicroPort CardioFlow Medtech Co., Ltd.. The trial plans to enroll 100 participants.