Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease.
The study is designed as a post-market, observational, non-interventional retrospective and prospective registry.
In order to monitor the ongoing safety of the Perceval S as part of regulatory requirements, the study aims to retrospectively collect safety outcomes and performance data in patients with aortic valve disease implanted with Perceval S since 2022. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.
Serious Adverse Events (SAEs) such as valve-related death, structural valve deterioration, cerebral thromboembolism, stroke, Transient Ischemic Attack, non-cerebral thromboembolism, major bleeding, re-operation will be studied to describe the safety profile of the valve.
Hemodynamic data from site reported echocardiography finding (mean gradient, peak gradient, effective orifice area, effective orifice area indexed, incidence and degree of PVL and central leak) at hospital discharge will also be evaluated. Data of approximately 80 subjects will be collected in four clinical sites in China.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject implanted with Perceval S sutureless prosthetic heart valve | Subjects who have been implanted with Perceval S sutureless prosthetic heart valve from 2022 onward and subjects that will be implanted up to study closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perceval S sutureless heart valve | Device | Aortic Valve Replacement with Perceval S sutureless heart valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | The number and percentage of subjects died | up to 1 year |
| Structural valve deterioration | The number and percentage of subjects with Structural valve deterioration | up to 1 year |
| Cerebral thromboembolism | The number and percentage of subjects with Cerebral thromboembolism | up to 1 year |
| Stroke | The number and percentage of subjects with stroke | up to 1 year |
| Transient Ischemic Attack (TIA) | The number and percentage of subjects with Transient Ischemic Attack (TIA) | up to 1 year |
| Non-cerebral thromboembolism | The number and percentage of subjects with non-cerebral thromboembolism | up to 1 year |
| Major bleeding | The number and percentage of subjects with major bleeding | up to 1 year |
| Re-operation | The number and percentage of subjects with re-operation | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Mean Pressure Gradient (MPG) | Decrease of MPG from baseline | at discharge or 7 days post-procedure (whichever comes first) |
| Aortic Peak Pressure Gradient (PPG) | Decrease of PPG from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Subject (legal representative or family member) who do not provide consent to the data collection
Not provided
Not provided
Not provided
Not provided
Subjects who have been implanted with Perceval S sutureless prosthetic heart valve from 2022 onward and subjects that will be implanted up to study closure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Zhang | Contact | +86 138 1023 2090 | steven.zhang@corcym.com | |
| Michela Paroli | Contact | +393488660149 | michela.paroli@corcym.com |
| Name | Affiliation | Role |
|---|---|---|
| Sara Gaggianesi | Corcym S.r.l | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| at discharge or 7 days post-procedure (whichever comes first) |
| Effective Orifice Area (EOA) | Increase of EOA from baseline | at discharge or 7 days post-procedure (whichever comes first) |
| Effective Orifice Area Index (EOAi) | Increase of EOAi from baseline | at discharge or 7 days post-procedure (whichever comes first) |
| Aortic Regurgitation | incidence and degree of paravalvular and central leak | at discharge or 7 days post-procedure (whichever comes first), |