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.
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…
Contacts
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