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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05941455
Study type Interventional
Source Jilin Venus Haoyue Medtech Limited
Contact Destino
Phone +493045932260
Email nadia.destino@dhzc-charite.de
Status Not yet recruiting
Phase N/A
Start date October 31, 2023
Completion date October 31, 2029
View Details
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