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

NCT ID: NCT05424653

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-31

Brief Summary

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

Detailed 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.

Conditions

Aortic Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe Symptomatic Aortic Regurgitation

Patients will be treated with transcatheter aortic valve system

Group Type: EXPERIMENTAL

Transcatheter Aortic Valve System

Intervention Type: DEVICE

Procedure: Transcatheter Aortic Valve Replacement

Interventions

Transcatheter Aortic Valve System

Procedure: Transcatheter Aortic Valve Replacement

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Silara Meditech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jincheng Liu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital,the Air Force Medical University

Central Contacts

Yang Liu

Role: CONTACT

liuyangxijing@126.com

+86 13519135591

Other Identifiers

Silara202101

Identifier Type: -

Identifier Source: org_study_id