A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
NCT05941455 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 155
Last updated 2023-07-12
Summary
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
Conditions
- Aortic Valve Disease
- Cardiovascular Diseases
Interventions
- DEVICE
-
Venus-Neo Surgical Aortic Valve
Implant of a Venus-Neo Surgical Aortic Valve
Sponsors & Collaborators
-
Jilin Venus Haoyue Medtech Limited
lead INDUSTRY
Principal Investigators
-
Volkmar Falk · Deutsches Herzzentrum Berlin-Charité
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-31
- Primary Completion
- 2025-10-31
- Completion
- 2029-10-31
Countries
- Germany
Study Locations
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