Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
NCT05275088 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2023-11-18
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.
Conditions
- Atrioventricular Annular Calcification
- Failed Prosthetic Atrioventricular Valve/ Annulus Repair
Interventions
- DEVICE
-
Prizvalve® system
Transcatheter atrioventricular valve replacement
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
collaborator OTHER -
Shanghai NewMed Medical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-09
- Primary Completion
- 2024-03-31
- Completion
- 2028-06-10
Countries
- China
Study Locations
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