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

Not Applicable

Recruiting

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

• Registration Number: NCT04893603
• 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 Aortic Stenosis with or without Moderate or Lower Degree Regurgitation

Detailed Description

Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study.

Study Timeline

• Study Start: 2020-12-16
• Status Verified: 2021-04
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19
• Primary Completion: 2022-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe Aortic Valve Stenosis	Transcatheter Aortic Valve System	Patients will be treated with Transcatheter Aortic Valve Systerm

Primary Outcome Measures

Name	Time	Method
Rate of All-cause Mortality	12 months	Percentage of subjects who died from all causes in this population.

Secondary Outcome Measures

Name	Time	Method
Incidence of major vascular complications	Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.
Incidence of Other TAVI-related Complications	Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years	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
Quality of Life Assessment	30 days, 6 months,and 12 months	SF-12
Incidence of Stroke	7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Exchange Systerm 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.
Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL	Immediate post-procedure, 7days or discharge, 30 days, 6 months ,12months and 2-5 years	The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document
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.
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.
Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))	7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of Permanent Pacemaker Implantation	7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of Conduction disturbances and cardiac arrhythmias	Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years
Rate of Device Success	Immediate post- procedure	Device Success is defined as a composite of : 1. Absence of procedural mortality AND; 2. Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND; 3. Correct positioning of prosthetic heart valve into the proper anatomical location AND; 4. Intended performance of the prosthetic heart valve (mean aortic valve gradient\<20 mmHg or peak velocity\<3 m/s, and no severe prosthetic valve regurgitation or PVL)
Retrieval System Performance(if using)	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.
Rate of All-cause Mortality	Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.
NYHA function	7 days or discharge, 30 days, 6 months ,12 months and 2-5 years
Incidence of Myocardial Infarction	Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.
Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)	Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Incidence of Bleeding (life-threatening or disabling and major)	Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.

Trial Locations

Locations (1)

Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, China