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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Perceval S sutureless heart valve

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Steven Zhang; Phone Number: +86 138 1023 2090; Email: steven.zhang@corcym.com
• Study Contact Backup: Name: Michela Paroli; Phone Number: +393488660149; Email: michela.paroli@corcym.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Perceval S sutureless heart valve; Aortic Valve Replacement with Perceval S sutureless heart valve

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),

Collaborators and Investigators

• Sponsor: Corcym S.r.l
• Investigators: Study Director: Sara Gaggianesi, Corcym S.r.l

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CCH803

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No