Aortic Valve ReplacementNCT00860730
PERCEVAL Pivotal Trial
A study testing Aortic valve replacement with Perceval aortic heart valve in people with Aortic Valve Replacement, run by Corcym S.r.l at 9 sites in 4 countries.
Trial summary
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Aortic valve replacement with Perceval aortic heart valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Jan 2009to Oct 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects of 75 years or older;
- Subjects with aortic valve stenosis or steno-insufficiency;
- Subjects at high surgical risk and candidates for aortic valve replacement with a biological prosthesis;
- Subjects in NYHA functional classes III and IV with the Logistic EuroSCORE greater than 5%.
- Subjects who have agreed to participation in the clinical evaluation and who have signed the informed consent;
- Subjects who are willing to undergo all the medical follow-ups and echocardiographic examinations and laboratory tests that form part of this present protocol.
Who cannot join
- Subjects involved in any other clinical study for drugs or devices;
- Subjects who have previously undergone implantation with the Perceval S prosthesis being assessed;
- Subjects with previous implantation of valve prostheses or annuloplasty ring in mitral position;
- Subjects requiring simultaneous procedures, apart from septal myectomy and/or coronary by-pass;
- Subjects with aneurysmal dilation or dissection of the ascending aortic wall needing surgical correction;
- Subjects needing non elective intervention;
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- Subjects with aortic annulus (after procedure for decalcification) of dimensions such that the implantation of a valve of size 21 or 23 mm is not possible (direct intra-operative measurement with sizer), in accordance with the indications reported in the Investigator's Brochure;
- Subjects with active endocarditis;
- Subjects with active myocarditis;
- Subjects with any anomaly of the coronary ostia determined through pre-operative coronary angiogram or during intervention itself;
- Subjects with congenital bicuspid aortic valve;
- Subjects with aortic root enlargement, where the ratio between observed and expected diameters (calculated as a function of age and patient body surface area) is > 1.3;
- Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter is > 1.3;
- Subjects with myocardial infarct < =90 days;
- Subjects with known hypersensitivity to nickel alloys.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
France4 sites
CHRU de Lille
Lille, 59037
Hopital Guillaume et René Laennec
Nantes, 44093
Institut Mutualiste Montsouris
Paris, 75014
Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604
Germany3 sites
Ruhr Universität Bochum
Bochum, 44789
Westdeutsches Herzzentrum
Essen, 45122
Medizinische Hochschule Hannover
Hanover, 30625
About this study
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.
Read the detailed description
The design of the Perceval S prosthesis stems from the intention to offer an alternative to traditional flexible prostheses (stented and stentless biological valves) using conventional open-heart surgery. As a result of the sutureless implant procedure, in fact, patients could benefit from:
Reducing aortic clamp times, with subsequent overall reduction of surgical timing and therefore reduction in related risks; Avoiding to pass the stitches through the annulus and sutures knotting, with consequent less risk of tearing aortic annulus and wall, damaging the bundle of His, embolizing foreign material in the vascular system.
- Conditions
- Aortic Valve Replacement
- Being tested
- Aortic valve replacement with Perceval aortic heart valve
- Keywords
- Aortic valve replacement, Aortic stenosis, Biological valve, Sutureless valve, Stented valve, Aortic Valve Disease
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacement with Perceval aortic heart valveDevice
Replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Perceval S | Experimental | Not described Receives: Device: Aortic valve replacement with Perceval aortic heart valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety of the Perceval S prosthesis in terms of percentage incidence of mortality and morbidity at 3-6 months after implant
Measured: 6 months
Secondary outcomes (1)
Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and 12 months after implant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve ReplacementStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Haverich, Prof, Principal investigator, Hannover Medizinische Hochschule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860730
- Sponsor's protocol ID
- V10801
- Status last verified
- Jan 2019
- First submitted
- 11 Mar 2009
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERCEVAL Pivotal Trial
- ClinicalTrials.gov ID
- NCT00860730
- Acronym / sponsor ID
- V10801
- Conditions
- Aortic Valve Replacement
- Keywords
- Aortic valve replacement, Aortic stenosis, Biological valve, Sutureless valve, Stented valve, Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Mar 2009 (estimated)
- 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 clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.
Detailed description
The design of the Perceval S prosthesis stems from the intention to offer an alternative to traditional flexible prostheses (stented and stentless biological valves) using conventional open-heart surgery. As a result of the sutureless implant procedure, in fact, patients could benefit from:
Reducing aortic clamp times, with subsequent overall reduction of surgical timing and therefore reduction in related risks; Avoiding to pass the stitches through the annulus and sutures knotting, with consequent less risk of tearing aortic annulus and wall, damaging the bundle of His, embolizing foreign material in the vascular system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perceval S | Experimental | Device: Aortic valve replacement with Perceval aortic heart valve |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Subjects of 75 years or older;
- Subjects with aortic valve stenosis or steno-insufficiency;
- Subjects at high surgical risk and candidates for aortic valve replacement with a biological prosthesis;
- Subjects in NYHA functional classes III and IV with the Logistic EuroSCORE greater than 5%.
- Subjects who have agreed to participation in the clinical evaluation and who have signed the informed consent;
Key exclusion criteria (15 listed)
- Subjects involved in any other clinical study for drugs or devices;
- Subjects who have previously undergone implantation with the Perceval S prosthesis being assessed;
- Subjects with previous implantation of valve prostheses or annuloplasty ring in mitral position;
- Subjects requiring simultaneous procedures, apart from septal myectomy and/or coronary by-pass;
- Subjects with aneurysmal dilation or dissection of the ascending aortic wall needing surgical correction;
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 aortic heart valveReplacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis | Device | Perceval S |
Primary outcome
Evaluation of the safety of the Perceval S prosthesis in terms of percentage incidence of mortality and morbidity at 3-6 months after implant
Time frame: 6 months
1 secondary outcome
Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and 12 months after implant
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- WebsiteLink provided by the sponsor.
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Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement
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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.
Axel Haverich, Prof principal investigator
Hannover Medizinische Hochschule
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic valve replacement with Perceval aortic heart valve in people with Aortic Valve Replacement, run by Corcym S.r.l at 9 sites in 4 countries.
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 6 inclusion and 15 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: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Germany, Belgium, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the safety of the Perceval S prosthesis in terms of percentage incidence of mortality and morbidity at 3-6 months after implant (time frame: 6 months). 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 8 Jul 2022.