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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05941455 on ClinicalTrials.gov