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

A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis

This study is testing a new heart valve system to see if it safely helps people with severe aortic stenosis feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 145 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. (Industry-sponsored)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT04414878 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 70 years or older with symptomatic severe aortic stenosis who are considered high-risk for surgical aortic valve replacement.

Not a fit: Patients with acute myocardial infarction in the last 30 days or those with unsuitable aortic root anatomy for valve implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe aortic stenosis who are at high risk for surgical valve replacement.

How similar studies have performed: Other studies involving transcatheter aortic valve replacements have shown success, indicating that this approach is promising and not entirely novel.

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.

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• 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

Conditions Aortic Stenosis