Cingularbio® Heart Valve Clincial Study

Shanghai Cingularbio

Status: Completed

Conditions: Diseases of Mitral and Aortic Valves

Treatments: Device: Cingularbio® Aortic valve replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02755220

XZBM-2015-01

Details and patient eligibility

About

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

Full 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

Enrollment: 197 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria were as follows: 1) patient who had heart valve disease requiring a surgical replacement as indicated in the preoperative evaluation; 2) patient aged between 60-85 years; 3) patient whose preoperative heart function less than NYHA functional class IV; 4) patient who signed the informed consent before surgery; 5) patient who agrees to finish the follow-up. The exclusion criteria were as follows: 1) patient with prior valve replacement; 2) patient who requires concomitant tricuspid or pulmonary valve replacement; 3) patient who requires concomitant coronary artery bypass graft surgery; 4) patient with active infective endocarditis or drug abuse; 5) patient whose life time expectancy less than 12 months; 6) patient who was unable to follow anticoagulation treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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197 participants in 1 patient group

Cingularbio® Heart valve

Experimental group

Description:

the patients will replaced by artificial heart valve

Treatment:

Device: Cingularbio® Aortic valve replacement