Actively Recruiting
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
Led by Shanghai NewMed Medical Co., Ltd. · Updated on 2023-11-18
73
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
Sponsors
S
Shanghai NewMed Medical Co., Ltd.
Lead Sponsor
T
The General Hospital of Northern Theater Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Symptomatic severe aortic valve stenosis confirmed by echocardiography
- Cardiac function classified as NYHA class II or higher
- Life expectancy greater than 12 months
- Anatomically suitable for transcatheter aortic valve implantation
- Evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery or refused surgery with high surgical risk
- Able to understand the study purpose, provide informed consent, and willing to comply with examinations and follow-ups
You will not qualify if you...
- Acute myocardial infarction within 1 month before treatment
- Congenital unicuspid aortic valve
- Any therapeutic cardiac operation within 30 days of the procedure (except PCI or permanent pacemaker implantation)
- Presence of other prosthetic heart valves, prosthetic rings, or severe mitral valve insufficiency (>3+)
- Hematologic disorders or abnormalities contraindicating surgery
- Untreated severe coronary artery stenosis requiring revascularization
- Hemodynamic or respiratory instability requiring continuous mechanical heart support or ventilation
- Need for emergency surgery
- Hypertrophic cardiomyopathy with obstruction
- Severe left ventricular dysfunction with ejection fraction less than 20%
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Left ventricular outflow tract obstruction
- History of acute peptic ulcer or upper gastrointestinal bleeding within 3 months
- Allergy or resistance to cobalt-chromium alloy, contrast agents, or related components
- Unable to receive anticoagulation or antiplatelet therapy
- Cerebrovascular accident within 3 months (excluding transient ischemic attack)
- Severe aortic diseases such as abdominal or thoracic aortic aneurysm
- Active infective endocarditis or other active infections
- Participation in other drug or device clinical trials without reaching primary outcome
- Poor compliance judged by investigator preventing study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai NewMed Medical Co., Ltd.
Shanghai, China
Actively Recruiting
Research Team
C
Chunyang Wang
CONTACT
X
Xuyang Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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