Aortic Valve DiseasePERFECTNCT03481387
PERCEVAL S Valve Clinical Study for Chinese Registration
A study testing Aortic Valve Replacement with Perceval S sutureless heart valve in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Corcym S.r.l at 1 site in China.
Trial summary
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis
- What is being tested?
- Aortic Valve Replacement with Perceval S sutureless heart valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2018to 25 Feb 2024
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject of age > 60 years.
- Subject with aortic valve stenosis or steno-insufficiency.
- Subject has signed the informed consent.
- Subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery
- Subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable).
Who cannot join
- Subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position.
- Subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
- Subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (CABG).
- Subject has active endocarditis.
- Subject has active myocarditis
- Subject has aneurysmal dilation or dissection of the ascending aortic wall.
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- Subject is drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
- Subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
- Subject with known hypersensitivity to nickel alloys.
- Subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
- Subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized for ≥30 days prior to the planned valve implant surgery.
- Subject is known to be noncompliant or is unlikely to complete the study.
- Subject with an aortic root enlargement, where the ratio between the diameter of the STJ and the annulus diameter, assessed by TEE, is > 1.3. Or for other anatomical reasons that not suitable for PERCEVAL S per IB.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve.
The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Being tested
- Aortic Valve Replacement with Perceval S sutureless heart valve
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Valve Replacement with Perceval S sutureless heart valveDevice
Patients will be treated with the PERCEVAL S heart valve (PERCEVAL S valve) which is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The PERCEVAL S valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
| Study group | Role | What they receive |
|---|---|---|
| Aortic Valve Replacement with Perceval S sutureless heart valve | Other | Patient undergoing Aortic Valve Replacement with Perceval S sutureless heart valve Receives: Device: Aortic Valve Replacement with Perceval S sutureless heart valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days)
The primary endpoint includes thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) per CEC adjudication
The number and percentage of subjects with free from thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death will be presented, along with individual component of the success.
Measured: at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start26 Jan 2018
- Primary completion25 Sep 2020
- Study completion25 Feb 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
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
- NCT03481387
- Sponsor's protocol ID
- TPS004
- Acronym
- PERFECT
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2018
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- PERCEVAL S Valve Clinical Study for Chinese Registration
- ClinicalTrials.gov ID
- NCT03481387
- Acronym / sponsor ID
- PERFECT / TPS004
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 29 Mar 2018 (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.
This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve.
The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic Valve Replacement with Perceval S sutureless heart valve | Other | Device: Aortic Valve Replacement with Perceval S sutureless heart valvePatient undergoing Aortic Valve Replacement with Perceval S sutureless heart valve |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject of age > 60 years.
- Subject with aortic valve stenosis or steno-insufficiency.
- Subject has signed the informed consent.
- Subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery
- Subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable).
Key exclusion criteria (13 listed)
- Subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position.
- Subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
- Subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (CABG).
- Subject has active endocarditis.
- Subject has active myocarditis
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 |
|---|---|---|
| Aortic Valve Replacement with Perceval S sutureless heart valvePatients will be treated with the PERCEVAL S heart valve (PERCEVAL S valve) which is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The PERCEVAL S valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site. | Device | Aortic Valve Replacement with Perceval S sutureless heart valve |
Primary outcome
composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days)
Time frame: at one year
The primary endpoint includes thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) per CEC adjudication The number and percentage of subjects with free from thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death will be presented, along with individual component of the success.
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.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic Valve Replacement with Perceval S sutureless heart valve in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Corcym S.r.l at 1 site in China.
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 5 inclusion and 13 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.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint of thromboembolism, all bleeding, all paravalvular leak and endocarditis, structural valve deterioration (SVD) and late all cause death (>30 days) (time frame: at one year). 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.