A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation

Chengdu Silara Meditech Inc.1 site in 1 country120 target enrollmentDecember 16, 2020

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Chengdu Silara Meditech Inc.
Enrollment: 120
Locations: 1
Primary Endpoint: Rate of All-cause Mortality
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 16, 2020

End Date

December 31, 2026

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chengdu Silara Meditech Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥70 years old;
•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/m
•NYHA Functional Class ≥II;
•Life expectancy after aortic valve implantation thought to be \>1 year;
•Native valvular or peripheral vascular anatomy is appropriate for TAVR;
•Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery;
•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

•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);
•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);
•Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
•Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (\>3+) mitral insufficiency, or Gorlin syndrome;
•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;
•Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
•Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) \<20%;
•Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
•Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure;
•Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure, including TIA;

Outcomes

Primary Outcomes

Rate of All-cause Mortality

Time Frame: 12 months

Percentage of subjects who died from all causes in this population.

Secondary Outcomes

Quality of Life Assessment(30 days, 6 months,and 12 months)
Incidence of Stroke(7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.)
Exchange Systerm Evaluation(Immediate post- procedure)
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)
Delivery System Performance(Immediate post- procedure)
Rate of Procedure Success(Immediate post- procedure)
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)
Retrieval System Performance(if using)(Immediate post- procedure)
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.)
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)