Diseases of Mitral and Aortic Valves
Conditions
Brief 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
Interventions
DEVICECingularbio® Aortic valve replacement
the patients will be replaced by Cingularbio heart valve
Sponsors
Shanghai Cingularbio Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| device related adverse valve events | 12 month | device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the difference between baseline and 1 year in Effective orifice area (EOA) | 1year | the difference between baseline and 1 year in Effective orifice area (EOA) in echocardiographic hemodynamic |
| the difference between baseline and 1 year in pressure gradient (PG) | 1year | the difference between baseline and 1 year in pressure gradient (PG) in echocardiographic hemodynamic |
| the difference between baseline and 1 year in Peak aortic valve velocity | 1year | the difference between baseline and 1 year in Peak aortic valve velocity in echocardiographic hemodynamic |
| improvement in NYHA functional class | 1year | the NYHA score between baseline and 1 year |
| rate of procedural success | post-operative | device implant success |
| structural valve deterioration | 1 year | the SVD rate at 1 year |
| reoperation | 1 year | the reoperation rate at 1 year |
| valve-related adverse events | 1 year | all valve related AEs (not primary endpoint events) at 1 year |
| mortality | 1 year | the mortality rate at 1 year |
Countries
Belgium, China, Poland
Outcome results
None listed