Evaluation of the Efficacy and Safety of the Transcatheter Aortic Valve Replacement System in Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk

Shanghai NewMed Medical Co., Ltd.1 site in 1 country120 target enrollmentJanuary 19, 2021

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Shanghai NewMed Medical Co., Ltd.
Enrollment: 120
Locations: 1
Primary Endpoint: Freedom from all-cause mortality
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Detailed Description

This study is an multicenter, single-arm, prospective, safety and performance clinical study.

Registry

clinicaltrials.gov

Start Date

January 19, 2021

End Date

June 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai NewMed Medical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 65 years ;
•Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm2, or AVA \<0.5cm2 /m2);
•Life expectancy\> 12 months;
•Patients who are anatomically suitable for transcatheter aortic valve implantation;
•After evaluation by two or more cardiovascular surgeons, patients who are unsuitable for surgery; or patients who refuse surgery after sufficient communication by the surgeons and are at high risk of routine surgery;
•Patients who can understand the purpose of the trial, voluntarily participate in and signed informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria

•Acute myocardial infarction occurred within 1 month before this treatment;
•Congenital single leaf aortic valve;
•Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days;
•The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation (\>3+);
•Blood system diseases or abnormalities, including leukopenia (WBC\<3×109/L), acute anemia (HB \<90g/L), thrombocytopenia (PLT\<50×109/L), bleeding constitution and coagulopathy ；
•Untreated severe coronary artery stenosis that requires revascularization;
•Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
•Patients who need emergency surgery for any reason;
•Hypertrophic cardiomyopathy with obstruction;
•Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;