Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
| Condition(s) | Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair. |
| Who can participate | 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 years and older who is not in pregnancy or lactation; 4. Life expectancy\>12 months; 5. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement; 6. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement; 7. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups; 8. Pat |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shanghai NewMed Medical Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2022-03-09 |
| NCT ID | NCT05275088 |
| Official listing | https://clinicaltrials.gov/study/NCT05275088 |