Aortic Valve DiseaseNCT06011148
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
An observational study of Aortic Valve Disease, run by Corcym S.r.l.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Perceval S sutureless heart valve
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 1. Subject (legal representative or family member) who do not provide consent to the data collection
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Aortic Valve Disease
- Being tested
- Perceval S sutureless heart valve
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceval S sutureless heart valveDevice
Aortic Valve Replacement with Perceval S sutureless heart valve
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Perceval S sutureless heart valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The number and percentage of subjects died
Measured: up to 1 year
Structural valve deterioration
The number and percentage of subjects with Structural valve deterioration
Measured: up to 1 year
Cerebral thromboembolism
The number and percentage of subjects with Cerebral thromboembolism
Measured: up to 1 year
Stroke
The number and percentage of subjects with stroke
Measured: up to 1 year
Transient Ischemic Attack (TIA)
The number and percentage of subjects with Transient Ischemic Attack (TIA)
Measured: up to 1 year
Non-cerebral thromboembolism
The number and percentage of subjects with non-cerebral thromboembolism
Measured: up to 1 year
Major bleeding
The number and percentage of subjects with major bleeding
Measured: up to 1 year
Re-operation
The number and percentage of subjects with re-operation
Measured: up to 1 year
Secondary outcomes (5)
Aortic Mean Pressure Gradient (MPG)
Decrease of MPG from baseline
Measured: at discharge or 7 days post-procedure (whichever comes first)
Aortic Peak Pressure Gradient (PPG)
Decrease of PPG from baseline
Measured: at discharge or 7 days post-procedure (whichever comes first)
Effective Orifice Area (EOA)
Increase of EOA from baseline
Measured: at discharge or 7 days post-procedure (whichever comes first)
Effective Orifice Area Index (EOAi)
Increase of EOAi from baseline
Measured: at discharge or 7 days post-procedure (whichever comes first)
Aortic Regurgitation
incidence and degree of paravalvular and central leak
Measured: at discharge or 7 days post-procedure (whichever comes first),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Gaggianesi, Study director, Corcym S.r.l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011148
- Sponsor's protocol ID
- CCH803
- Status last verified
- Mar 2024
- First submitted
- 1 Aug 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
- ClinicalTrials.gov ID
- NCT06011148
- Acronym / sponsor ID
- CCH803
- Conditions
- Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject implanted with Perceval S sutureless prosthetic heart valve | – | Device: Perceval S sutureless heart valveSubjects who have been implanted with Perceval S sutureless prosthetic heart valve from 2022 onward and subjects that will be implanted up to study closure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Subject (legal representative or family member) who do not provide consent to the data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceval S sutureless heart valveAortic Valve Replacement with Perceval S sutureless heart valve | Device | Subject implanted with Perceval S sutureless prosthetic heart valve |
Primary outcome
Mortality
Time frame: up to 1 year
The number and percentage of subjects died
Structural valve deterioration
Time frame: up to 1 year
The number and percentage of subjects with Structural valve deterioration
Cerebral thromboembolism
Time frame: up to 1 year
The number and percentage of subjects with Cerebral thromboembolism
Stroke
Time frame: up to 1 year
The number and percentage of subjects with stroke
Transient Ischemic Attack (TIA)
Time frame: up to 1 year
The number and percentage of subjects with Transient Ischemic Attack (TIA)
Non-cerebral thromboembolism
Time frame: up to 1 year
The number and percentage of subjects with non-cerebral thromboembolism
Major bleeding
Time frame: up to 1 year
The number and percentage of subjects with major bleeding
Re-operation
Time frame: up to 1 year
The number and percentage of subjects with re-operation
5 secondary outcomes
Aortic Mean Pressure Gradient (MPG)
Time frame: 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)
Effective Orifice Area (EOA)
Time frame: 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)
Aortic Regurgitation
Time frame: at discharge or 7 days post-procedure (whichever comes first),
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Gaggianesi study director
Corcym S.r.l
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Corcym S.r.l.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven Zhang (+86 138 1023 2090, steven.zhang@corcym.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.