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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cingularbio® Heart valve | Experimental | the patients will replaced by artificial heart valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cingularbio® Aortic valve replacement | Device | the patients will be replaced by Cingularbio heart valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| device related adverse valve events | device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| rate of procedural success | device implant success | post-operative |
| the difference between baseline and 1 year in Effective orifice area (EOA) | the difference between baseline and 1 year in Effective orifice area (EOA) in echocardiographic hemodynamic |
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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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| Name | Affiliation | Role |
|---|---|---|
| chunsheng wang | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiale Heelkunde | Leuven | Belgium | ||||
| Zhongshan Hospital of Fudan University |
the publication will be started after study close out
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| 1year |
| the difference between baseline and 1 year in pressure gradient (PG) | the difference between baseline and 1 year in pressure gradient (PG) in echocardiographic hemodynamic | 1year |
| the difference between baseline and 1 year in Peak aortic valve velocity | the difference between baseline and 1 year in Peak aortic valve velocity in echocardiographic hemodynamic | 1year |
| improvement in NYHA functional class | the NYHA score between baseline and 1 year | 1year |
| mortality | the mortality rate at 1 year | 1 year |
| structural valve deterioration | the SVD rate at 1 year | 1 year |
| reoperation | the reoperation rate at 1 year | 1 year |
| valve-related adverse events | all valve related AEs (not primary endpoint events) at 1 year | 1 year |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Klinika Kardiochirurgii | Katowice | Poland |
| Klinika Kardiochirurgii | Krakow | Poland |
| Klinika Kardiochirurgii | Warsaw | Poland |