Aortic Valve Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPerceval S sutureless heart valve
Aortic Valve Replacement with Perceval S sutureless heart valve
Sponsors
Corcym S.r.l
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject who has been implanted with Perceval S sutureless aortic heart valve 2. Subject (legal representative or family member) who has signed the approved informed consent or would provide verbal informed consent/ signed and dated informed consent, and available medical information
Exclusion criteria
1\. Subject (legal representative or family member) who do not provide consent to the data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-operation | up to 1 year | The number and percentage of subjects with re-operation |
| Mortality | up to 1 year | The number and percentage of subjects died |
| Structural valve deterioration | up to 1 year | The number and percentage of subjects with Structural valve deterioration |
| Cerebral thromboembolism | up to 1 year | The number and percentage of subjects with Cerebral thromboembolism |
| Non-cerebral thromboembolism | up to 1 year | The number and percentage of subjects with non-cerebral thromboembolism |
| Major bleeding | up to 1 year | The number and percentage of subjects with major bleeding |
| Stroke | up to 1 year | The number and percentage of subjects with stroke |
| Transient Ischemic Attack (TIA) | up to 1 year | The number and percentage of subjects with Transient Ischemic Attack (TIA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Peak Pressure Gradient (PPG) | at discharge or 7 days post-procedure (whichever comes first) | Decrease of PPG from baseline |
| Effective Orifice Area (EOA) | at discharge or 7 days post-procedure (whichever comes first) | Increase of EOA from baseline |
| Effective Orifice Area Index (EOAi) | at discharge or 7 days post-procedure (whichever comes first) | Increase of EOAi from baseline |
| Aortic Regurgitation | at discharge or 7 days post-procedure (whichever comes first), | incidence and degree of paravalvular and central leak |
| Aortic Mean Pressure Gradient (MPG) | at discharge or 7 days post-procedure (whichever comes first) | Decrease of MPG from baseline |
Contacts
Primary ContactSteven Zhang
Backup ContactMichela Paroli
Outcome results
None listed