Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

Recruiting N/A Interventional Study
Atrioventricular Annular Calcification Failed Prosthetic Atrioventricular Valve/ Annulus Repair
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Shanghai NewMed Medical Co., Ltd. · Industry
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About This Trial

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

Trial Locations
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Eligibility Criteria
1\. Inclusion criteria for patients with severe atrioventricular valve annular calcification: 1. Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed); 2. Patient with symptoms, and NYHA Functional Class≥Ⅱ; 3. 18 year…
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