NCT05941455

A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Jilin Venus Haoyue Medtech Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.

Conditions

• Aortic Valve Disease
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Venus-Neo Surgical Aortic Valve	Implant of a Venus-Neo Surgical Aortic Valve

Timeline

• Start date: 2023-10-31
• Primary completion: 2025-10-31
• Completion: 2029-10-31
• First posted: 2023-07-12
• Last updated: 2023-07-12

Locations

1 site across 1 country: Germany