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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06011148
• Other study ID #: CCH803
• Status: Not yet recruiting
• Start date: December 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Corcym S.r.l
• Contact: Steven Zhang
• Phone: +86 138 1023 2090
• Email: steven.zhang[@]corcym.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• Perceval S sutureless heart valve
Aortic Valve Replacement with Perceval S sutureless heart valve

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corcym S.r.l

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	The number and percentage of subjects died	up to 1 year
Primary	Structural valve deterioration	The number and percentage of subjects with Structural valve deterioration	up to 1 year
Primary	Cerebral thromboembolism	The number and percentage of subjects with Cerebral thromboembolism	up to 1 year
Primary	Stroke	The number and percentage of subjects with stroke	up to 1 year
Primary	Transient Ischemic Attack (TIA)	The number and percentage of subjects with Transient Ischemic Attack (TIA)	up to 1 year
Primary	Non-cerebral thromboembolism	The number and percentage of subjects with non-cerebral thromboembolism	up to 1 year
Primary	Major bleeding	The number and percentage of subjects with major bleeding	up to 1 year
Primary	Re-operation	The number and percentage of subjects with re-operation	up to 1 year
Secondary	Aortic Mean Pressure Gradient (MPG)	Decrease of MPG from baseline	at discharge or 7 days post-procedure (whichever comes first)
Secondary	Aortic Peak Pressure Gradient (PPG)	Decrease of PPG from baseline	at discharge or 7 days post-procedure (whichever comes first)
Secondary	Effective Orifice Area (EOA)	Increase of EOA from baseline	at discharge or 7 days post-procedure (whichever comes first)
Secondary	Effective Orifice Area Index (EOAi)	Increase of EOAi from baseline	at discharge or 7 days post-procedure (whichever comes first)
Secondary	Aortic Regurgitation	incidence and degree of paravalvular and central leak	at discharge or 7 days post-procedure (whichever comes first),