Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population

Study Overview
=================
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.

Official Title
-----------------
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Device: Perceval S sutureless heart valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject who has been implanted with Perceval S sutureless aortic heart valve 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject implanted with Perceval S sutureless prosthetic heart valve<br>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. | Device: Perceval S sutureless heart valve<br>* Aortic Valve Replacement with Perceval S sutureless heart valve<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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), |