Actively Recruiting
Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
Led by Shanghai NewMed Medical Co., Ltd. · Updated on 2023-11-18
15
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
Sponsors
S
Shanghai NewMed Medical Co., Ltd.
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
CONDITIONS
Official Title
Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have severe atrioventricular valve annular calcification with moderate or severe valve disease causing symptoms
- Be 18 years or older and not pregnant or breastfeeding
- Have a life expectancy longer than 12 months
- Be anatomically suitable for transcatheter atrioventricular valve replacement
- Be evaluated by a heart team and considered able to benefit from this valve replacement
- Be willing and able to understand the study, provide consent, and complete follow-ups
- Have high risk for surgery or severe comorbidities making surgery unsuitable, or have severely calcified valve annulus that cannot be operated
- Have had previous atrioventricular valve replacement or repair with severe valve regurgitation or stenosis and symptoms or hemolytic anemia requiring blood transfusion
You will not qualify if you...
- Had an acute heart attack within 30 days before treatment
- Had any heart surgery (not including PCI or pacemaker implant) within 30 days before treatment
- Plan to have surgery or catheter ablation for atrial fibrillation at the same time
- Have hypertrophic cardiomyopathy with obstruction
- Have severe left ventricular dysfunction with ejection fraction below 20%
- Have a heart clot, mass, or infection inside the heart
- Have had an acute stomach ulcer or upper gastrointestinal bleeding within 3 months
- Are allergic to cobalt-chromium alloy or contrast dye or cannot tolerate blood thinners
- Have active infective endocarditis or other active infection
- Had a stroke within 3 months before treatment, except transient ischemic attack
- Have poor compliance and cannot complete the study as required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here