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

Official title

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

Overview

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.

Interventions

• Device Transcatheter Aortic Valve System
  Procedure: Transcatheter aortic valve replacement

Primary outcome measures

• Rate of All-cause Mortality [Time frame: 12 months]

Secondary outcome measures (12)

• Rate of Device Success [Time frame: Immediate post- procedure]
• Rate of Procedure Success [Time frame: Immediate post- procedure]
• Delivery System Performance [Time frame: Immediate post- procedure]
• Retrieval System Performance(if using) [Time frame: Immediate post- procedure]
• Exchange Systerm Evaluation [Time frame: Immediate post- procedure]
• Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL [Time frame: Immediate post-procedure, 7days or discharge, 30 days, 6 months ,12months and 2-5 years]
• Quality of Life Assessment [Time frame: 30 days, 6 months,and 12 months]
• NYHA function [Time frame: 7 days or discharge, 30 days, 6 months ,12 months and 2-5 years]
• Rate of All-cause Mortality [Time frame: Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.]
• Incidence of Myocardial Infarction [Time frame: 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) [Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.]
• Incidence of Bleeding (life-threatening or disabling and major) [Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.]

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/m2.
• 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;
• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated;
• Patients with infective endocarditis or other active stage of infection;
• Currently participating in an investigational drug or another device trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fuwai Hospital, CAMS&PUMC — Beijing

Identifiers

NCT: NCT04893603 · Silara201901

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗