NCT04414878 VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
| NCT ID | NCT04414878 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai MicroPort CardioFlow Medtech Co., Ltd. |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 145 participants |
| Start Date | 2018-01-31 |
| Primary Completion | 2022-01-31 |
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
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 145 participants in total. It began in 2018-01-31 with a primary completion date of 2022-01-31.
⚠ 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 pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Eligibility Criteria
Inclusion Criteria: 1. Age≥70 years; 2. Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area\<0.8cm² (or EOA index\<0.5cm²/m²); 3. NYHA≥II class; 4. Estimated life-expectancy\>12 months after implantation of the prosthetic valve; 5. Anatomically suitable for the transcatheter aortic valve implantation procedure; 6. The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; 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: 1. Acute myocardial infarction (MI) in last 30 days before the treatment; 2. Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve； 3. Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation; 4. Previous implantation of heart valve at any position； 5. Hemodynamic instability requiring mechanical hemodynamic support devices; 6. Need for emergency surgery for any reason; 7. Hypertrophic cardiomyopathy with obstruction; 8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%;Severe right ventricular dysfunction; 9. Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months; 10. Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements. 11. Congenital aortic valve stenosis or unicuspid aortic valve; 12. Vascular diseases or anatomical condition preventing the device access; 13. Active endocarditis or other active infections at the time of treatment; 14. Participating in another trial and the primary endpoint is not achieved. 15. Inability to comply with the clinical investigation follow-up or other requirements.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04414878 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04414878 currently recruiting?
Yes, NCT04414878 is actively recruiting participants. Contact the research team at jbi@microport.com for enrollment information.
Where is the NCT04414878 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China, Chengdu, China, Hangzhou, China.
Who is sponsoring the NCT04414878 clinical trial?
NCT04414878 is sponsored by Shanghai MicroPort CardioFlow Medtech Co., Ltd.. The trial plans to enroll 145 participants.