Evaluation of a new transcatheter aortic valve system for severe aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to assess the safety and effectiveness of the Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System in treating severe aortic stenosis. It is a prospective, multi-center, single-arm study that will enroll 145 subjects across 18 clinical centers in China. Participants will undergo clinical or telephone follow-ups at various intervals post-implantation, including 30 days, 6 months, 12 months, and 2-5 years to monitor outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuwai Hospital
  Beijing, Beijing Municipality, China Recruiting
• Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• The Second Affiliated Hospital Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Bi Jie
• Email: jbi@microport.com
• Phone: (86)(21)38954600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.