Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
NCT05864456 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2023-11-18
Summary
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.
Conditions
- Aortic Valve Stenosis
Interventions
- DEVICE
-
Prizvalve Pro™ transcatheter aortic valve system
Transcatheter Aortic Valve Replacement
Sponsors & Collaborators
-
The General Hospital of Northern Theater Command
collaborator OTHER -
West China Hospital
collaborator OTHER -
Shanghai NewMed Medical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Yaling Han, Professor · Principal coordinating investigator
-
Mao Chen, Professor · coordinating investigator
-
Kai Xu, Professor · coordinating investigator
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-05
- Primary Completion
- 2024-06-30
- Completion
- 2028-05-31
Countries
- China
Study Locations
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