| NCT ID | NCT06535659 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai MicroPort CardioFlow Medtech Co., Ltd. |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 122 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 122 participants in total. It began in 2025-05-06 with a primary completion date of 2027-06-06.
⚠ 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
This is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months. Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
Eligibility Criteria
Inclusion Criteria: 1. Subjects of age≥ 18 years 2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR). 3. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements. Exclusion Criteria: 1. Pre-existing mechanical heart valve in aortic position 2. A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media 3. Ongoing sepsis, including active endocarditis 4. Anatomically not suitable for the VitaFlow Liberty TAV system 5. LVEF\<20% 6. Estimated life expectancy of less than 12 months 7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement 8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed 9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements 10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
Contact & Investigator
Darren Mylotte, MD
PRINCIPAL INVESTIGATOR
Galway University Hospital
Frequently Asked Questions
Who can join the NCT06535659 clinical trial?
This trial is open to participants of all sexes, aged 18 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 NCT06535659 currently recruiting?
Yes, NCT06535659 is actively recruiting participants. Contact the research team at lyyan@microport.com for enrollment information.
Where is the NCT06535659 trial being conducted?
This trial is being conducted at Galway, Ireland, Pisa, Italy, A Coruña, Spain, Madrid, Spain and 2 additional locations.
Who is sponsoring the NCT06535659 clinical trial?
NCT06535659 is sponsored by Shanghai MicroPort CardioFlow Medtech Co., Ltd.. The principal investigator is Darren Mylotte, MD at Galway University Hospital. The trial plans to enroll 122 participants.