Cingularbio® Heart Valve Clincial Study

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients

Conditions
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Diseases of Mitral and Aortic Valves

Intervention / Treatment
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* Device: Cingularbio® Aortic valve replacement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cingularbio® Heart valve<br>the patients will replaced by artificial heart valve | Device: Cingularbio® Aortic valve replacement<br>* the patients will be replaced by Cingularbio heart valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device related adverse valve events | device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak | 12 month | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |