Evaluating a new valve system for severe aortic stenosis

A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation

This study is testing a new valve system to see if it can safely help people with severe aortic stenosis who can't have traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Chengdu Silara Meditech Inc. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT04893603 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Transcatheter Aortic Valve System developed by Chengdu Silara Medtech Inc. in patients suffering from severe aortic stenosis. Participants will be assessed for their suitability based on specific echocardiographic criteria and will undergo the procedure if deemed appropriate by cardiothoracic surgeons. The study aims to provide a less invasive treatment option for patients who are not suitable for traditional surgical valve replacement. Follow-up visits will be conducted to monitor outcomes and ensure patient safety.

Who should consider this trial

Good fit: Ideal candidates are patients aged 70 and older with symptomatic severe aortic stenosis who are not suitable for surgical intervention.

Not a fit: Patients with anatomical conditions that are not appropriate for percutaneous valve implantation will not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a less invasive treatment option for elderly patients with severe aortic stenosis, improving their quality of life and survival rates.

How similar studies have performed: Other studies have shown success with transcatheter aortic valve replacement (TAVR) approaches, indicating a promising avenue for treatment in similar patient populations.

Eligibility criteria

Inclusion Criteria:

1. Age ≥70 years old;
2. Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area \<0.8 cm2 or aortic valve area index \<0.5 cm2/m2.
3. NYHA Functional Class ≥II;
4. Life expectancy after aortic valve implantation thought to be \>1 year;
5. Native valvular or peripheral vascular anatomy is appropriate for TAVR;
6. Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
7. Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.

Exclusion Criteria:

1. Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤21mm, or ≥30mm);
2. Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥2 ULN/or elevated TN (WHO definition);
3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
4. Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or Gorlin syndrome;
5. Hematological abnormality, defined as: Leukopenia (WBC \<3x10\^9/L), acute anemia (Hb \<90g/L), or thrombocytopenia (platelet count\<50×109/L),history of bleeding diathesis or coagulopathy;
6. Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
7. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%;
8. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
9. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
10. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;
11. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated;
12. Patients with infective endocarditis or other active stage of infection;
13. Currently participating in an investigational drug or another device trial.

Where this trial is running

Beijing

• Fuwai Hospital, CAMS&PUMC — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Yongjian Wu — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Moyang Wang

Conditions Aortic Valve Stenosis