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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
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.
|
Aortic Valve Replacement with Perceval S sutureless heart valve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: up to 1 year
|
The number and percentage of subjects died
|
up to 1 year
|
|
Structural valve deterioration
Time Frame: up to 1 year
|
The number and percentage of subjects with Structural valve deterioration
|
up to 1 year
|
|
Cerebral thromboembolism
Time Frame: up to 1 year
|
The number and percentage of subjects with Cerebral thromboembolism
|
up to 1 year
|
|
Stroke
Time Frame: up to 1 year
|
The number and percentage of subjects with stroke
|
up to 1 year
|
|
Transient Ischemic Attack (TIA)
Time Frame: up to 1 year
|
The number and percentage of subjects with Transient Ischemic Attack (TIA)
|
up to 1 year
|
|
Non-cerebral thromboembolism
Time Frame: up to 1 year
|
The number and percentage of subjects with non-cerebral thromboembolism
|
up to 1 year
|
|
Major bleeding
Time Frame: up to 1 year
|
The number and percentage of subjects with major bleeding
|
up to 1 year
|
|
Re-operation
Time Frame: up to 1 year
|
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)
Time Frame: at discharge or 7 days post-procedure (whichever comes first)
|
Decrease of MPG from baseline
|
at discharge or 7 days post-procedure (whichever comes first)
|
|
Aortic Peak Pressure Gradient (PPG)
Time Frame: at discharge or 7 days post-procedure (whichever comes first)
|
Decrease of PPG from baseline
|
at discharge or 7 days post-procedure (whichever comes first)
|
|
Effective Orifice Area (EOA)
Time Frame: at discharge or 7 days post-procedure (whichever comes first)
|
Increase of EOA from baseline
|
at discharge or 7 days post-procedure (whichever comes first)
|
|
Effective Orifice Area Index (EOAi)
Time Frame: at discharge or 7 days post-procedure (whichever comes first)
|
Increase of EOAi from baseline
|
at discharge or 7 days post-procedure (whichever comes first)
|
|
Aortic Regurgitation
Time Frame: at discharge or 7 days post-procedure (whichever comes first),
|
incidence and degree of paravalvular and central leak
|
at discharge or 7 days post-procedure (whichever comes first),
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sara Gaggianesi, Corcym S.r.l
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCH803
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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