Cingularbio® Heart Valve Clincial Study

S

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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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