To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency

Chengdu Silara Meditech

Status: Not yet enrolling

Conditions: Aortic Insufficiency

Treatments: Device: Transcatheter Aortic Valve System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05424653

Silara202101

Details and patient eligibility

About

To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency

Full description

Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study. To evaluate the feasibility , safety and effectiveness of Transcatheter aortic valve system.

Enrollment: 10 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 60 years old;
2. Subjects with symptomatic severe aortic valve regurgitation.
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 (defined as a risk of operative mortality after 30 days>50%，or severe irreversible comorbidities or other factors affecting surgery (e.g., porcelain aorta, frailty, chest malformation, severe liver disease, severe lung disease, etc.)), or patients at high risk of surgery（Euroscore≥20%, or STS≥8）,or patient not agree open 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 ≤20mm,or ≥28mm
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≥ 2x normal and/or elevated Tn (WHO definition).
3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).
4. Hematological abnormality, defined as: Leukopenia (WBC <3×109/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50×109/L), history of bleeding diathesis or coagulopathy.
5. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%.
6. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.
7. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure.
8. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA.
9. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine , clopidogrel and high polymer material, or sensitivity to contrast media, which cannot be adequately pre-medicated.
10. Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Severe Symptomatic Aortic Regurgitation

Experimental group

Description:

Patients will be treated with transcatheter aortic valve system

Treatment:

Device: Transcatheter Aortic Valve System