Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
- Conditions
- Aortic Valve Disease
- Interventions
- Device: Perceval S sutureless heart valve
- Registration Number
- NCT06011148
- Lead Sponsor
- Corcym S.r.l
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- Subject (legal representative or family member) who do not provide consent to the data collection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subject implanted with Perceval S sutureless prosthetic heart valve Perceval S sutureless 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.
- Primary Outcome Measures
Name Time Method Structural valve deterioration up to 1 year The number and percentage of subjects with Structural valve deterioration
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)
Re-operation up to 1 year The number and percentage of subjects with re-operation
Major bleeding up to 1 year The number and percentage of subjects with major bleeding
Mortality up to 1 year The number and percentage of subjects died
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
- Secondary Outcome Measures
Name Time Method Aortic Mean Pressure Gradient (MPG) at discharge or 7 days post-procedure (whichever comes first) Decrease of MPG 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 Peak Pressure Gradient (PPG) at discharge or 7 days post-procedure (whichever comes first) Decrease of PPG from baseline
Aortic Regurgitation at discharge or 7 days post-procedure (whichever comes first), incidence and degree of paravalvular and central leak