Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

Trial details

Who runs it

Shanghai NewMed Medical Co., Ltd.

Trial code

NCT05864456

Record updated

18 November 2023

Original description

The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ 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.Read full original descriptionShow less

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

The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ 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.

Inclusion: 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); Cardiac function NYHA ≥ II; Life expectancy> 12 months; Patients who are anatomically suitable for transcatheter aortic valve implantation; Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery; Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.

Exclusion: Acute myocardial infarction occurred within 1 month before this treatment; Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria); Patients who need emergency surgery for any reason; Patients who are unable to receive anticoagulation or antiplatelet therapy; Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research; Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+); Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate; Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation; A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components; Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc; Active infective endocarditis or other active infections; Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; Congenital unicuspid aortic valve; Untreated severe coronary artery stenosis that requires revascularization; Patients with hypertrophic cardiomyopathy with obstruction; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Patients with left ventricular outflow tract obstruction; Cerebrovascular accident occurred within 3 months, not including transient ischemic attack; The investigator judged that patient with poor compliance and could not complete the study as required.

ClinicalTrials.gov NCT05864456