Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorShanghai NewMed Medical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Acute myocardial infarction occurred within 1 month before this treatment;
Congenital unicuspid aortic valve;
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 with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+);
Trial design
Treatments tested in this trial
- Prizvalve Pro™ transcatheter aortic valve system
Treatment groups
73 Participants
are divided into 1 treatment groupSponsors and collaborators
Shanghai NewMed Medical Co., Ltd.
Lead sponsor
The General Hospital of Northern Theater Command
Collaborator
West China Hospital
Collaborator
Source ClinicalTrials.gov