NCT02755220

Cingularbio® Heart Valve Clincial Study

A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Shanghai Cingularbio Co. Ltd · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population

Detailed description

single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients

Conditions

• Diseases of Mitral and Aortic Valves

Interventions

Type	Name	Description
DEVICE	Cingularbio® Aortic valve replacement	the patients will be replaced by Cingularbio heart valve

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-01
• Completion: 2019-04-01
• First posted: 2016-04-28
• Last updated: 2022-04-28

Locations

5 sites across 3 countries: Belgium, China, Poland