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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
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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.
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Interventional model
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197 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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