Clinical trial NCT05424653: To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency
Official title: To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Insufficiency
Lead sponsor: Chengdu Silara Meditech Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of Device success
timeFrame: Immediate post- procedure
measure: Rate of Procedure success
timeFrame: Immediate post procedure
measure: Rate of none or trace AR
timeFrame: 30 days
measure: Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death
timeFrame: 30 days
measure: Incidence of MACCE
timeFrame: 30 days
Secondary outcomes:
measure: Delivery system performance
timeFrame: Immediate post-procedure
measure: Retrieval system performance (if need)
timeFrame: Immediate post-procedure
measure: Exchange system evaluation
timeFrame: Immediate post-procedure
measure: Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL
timeFrame: Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months
measure: Quality of Life Assessment
timeFrame: 30 days, 6 months,and 12 months
measure: NYHA function
timeFrame: 7 days or discharge, 30 days, 6 months ,12 months
measure: All-cause Mortality
timeFrame: Immediate post- procedure ,7 days /discharge, 6 months and 12 months
measure: Rate of moderate to severe AR
timeFrame: immediate post- procedure ,7 days /discharge, 6 months and 12 months
measure: Incidence of Myocardial Infarction
timeFrame: immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months
measure: Incidence of MACCE
timeFrame: Immediate post- procedure, 7 days /discharge, 6 months and 12months.
measure: Incidence of Bleeding(life-threatening or disabling and major)
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months
measure: Incidence of stroke
timeFrame: 7 days /discharge, 30 days, 6 months and 12 months
measure: Incidence of AKI
timeFrame: 7 days /discharge, 30 days, 6 months and 12 months
measure: Incidence of Permanent Pacemaker Implantation
timeFrame: 7 days /discharge, 30 days, 6 months and 12 months
measure: Incidence of major vascular complications
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
measure: Incidence of Conduction disturbances and cardiac arrhythmias
timeFrame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
measure: Incidence of other TAVI-related complications
timeFrame: at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital,the Air Force Medical University
name: Jincheng Liu
role: PRINCIPAL_INVESTIGATOR
References: