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

Not Applicable

• Conditions: Aortic Insufficiency
• Interventions: Device: Transcatheter Aortic Valve System

• Registration Number: NCT05424653
• Lead Sponsor: Chengdu Silara Meditech Inc.

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Last Update Submitted: 2022-06-15
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21
• Study Start: 2022-08-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe Symptomatic Aortic Regurgitation	Transcatheter Aortic Valve System	Patients will be treated with transcatheter aortic valve system

Primary Outcome Measures

Name	Time	Method
Rate of Procedure success	Immediate post procedure	Procedure Success is defined as no death, stroke, myocardial infarction and renal failure occurred within 72 hours after the operation on the basis of the final device success.
Rate of none or trace AR	30 days
Rate of Device success	Immediate post- procedure	Device Success is defined as a composite of : Absence of procedural mortality AND Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND Correct positioning of prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (mean aortic valve gradient\<20 mmHg or peak velocity\<3 m/s, and no moderate or more prosthetic valve regurgitation
Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death	30 days	Percentage of subjects who died from all causes in this population
Incidence of MACCE	30 days	MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias

Secondary Outcome Measures

Name	Time	Method
Quality of Life Assessment	30 days, 6 months,and 12 months	SF-12
Incidence of Myocardial Infarction	immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months
Retrieval system performance (if need)	Immediate post-procedure	Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL	Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months	The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document
Incidence of AKI	7 days /discharge, 30 days, 6 months and 12 months	including AKIN stage 2 and 3,or renal replacement therapy (RRT:Hemodialysis, abdomen Cavity dialysis, hemofiltration)
Delivery system performance	Immediate post-procedure	Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
All-cause Mortality	Immediate post- procedure ,7 days /discharge, 6 months and 12 months
Incidence of MACCE	Immediate post- procedure, 7 days /discharge, 6 months and 12months.	including death, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias
Incidence of Bleeding(life-threatening or disabling and major)	Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months
Exchange system evaluation	Immediate post-procedure	Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
NYHA function	7 days or discharge, 30 days, 6 months ,12 months
Incidence of stroke	7 days /discharge, 30 days, 6 months and 12 months
Incidence of other TAVI-related complications	at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month	including transfer to surgery , accidental heart-lung machine, coronary obstruction, ventricular septal rupture, mitral valve damage or dysfunction，cardiac tamponade，endocarditis ，valvular thrombus，valve migration(shifting, detachment, embolism, error deployment）,valve in valve
Rate of moderate to severe AR	immediate post- procedure ,7 days /discharge, 6 months and 12 months
Incidence of Permanent Pacemaker Implantation	7 days /discharge, 30 days, 6 months and 12 months
Incidence of Conduction disturbances and cardiac arrhythmias	Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
Incidence of major vascular complications	Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months