NCT04893603 To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
| NCT ID | NCT04893603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chengdu Silara Meditech Inc. |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-12-16 |
| Primary Completion | 2022-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 120 participants in total. It began in 2020-12-16 with a primary completion date of 2022-12-31.
⚠ 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
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
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.
Contact & Investigator
Yongjian Wu
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT04893603 clinical trial?
This trial is open to participants of all sexes, aged 70 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 NCT04893603 currently recruiting?
Yes, NCT04893603 is actively recruiting participants. Contact the research team at wangmoyang1983@vip.sina.com for enrollment information.
Where is the NCT04893603 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04893603 clinical trial?
NCT04893603 is sponsored by Chengdu Silara Meditech Inc.. The principal investigator is Yongjian Wu at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 120 participants.