Aortic Valve ReplacementCAVALIERNCT01368666
Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark
A study testing Perceval S Valve Prosthesis in people with Aortic Valve Replacement, run by Corcym S.r.l at 26 sites in 8 countries.
Trial summary
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Perceval S Valve Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 23 Feb 2010to 31 Jan 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects of age > 65 years;
- Subjects with aortic valve stenosis or steno-insufficiency;
- Subjects in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement with a biological prosthesis;
- Subjects willing to sign the informed consent;
- Subjects willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the Study
Who cannot join
- Subjects involved in any other clinical study for drugs or devices;
- Subjects with a previously implanted Perceval S prosthesis, within the clinical study, that requires replacement
- Subjects with previous implantation of valve prostheses or annuloplasty ring not being replaced by the study valve
- Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass
- Subjects who require double or multiple valve replacement or repair in whom the mitral, tricuspid, or pulmonic valve would be replaced with a non-Perceval S valve or repaired
- Subjects with aneurysmal dilation or dissection of the ascending aortic wall
Show all 19Show fewer
- Subjects needing non elective intervention
- Subjects with active endocarditis
- Subjects with active myocarditis
- Subjects with congenital bicuspid aortic valve
- Subjects with aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is > 1.3 (see Attachment 1 for reference)
- Subjects with aortic root height (measured from aortic annulus to sino-tubular junction) ≥ 21 mm for size 21, ≥ 22.5 mm for size 23 and ≥ 24 mm for size 25, and ≥ 25 mm for size XL/27
- Subjects with myocardial infarction < 90 days before the planned valve implant surgery
- Subjects with known hypersensitivity to nickel alloys
- The subject has a documented history of substance (drug or alcohol) abuse
- The subject is a prison inmate, institutionalized, or is unable to give informed consent;
- The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or the implant of the device produces an unacceptable increased risk to the patient
- The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
- The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned valve implant surgery
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
Germany12 sites
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, 29549
RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH
Bad Neustadt an der Saale, 97616
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Ruhr Universität Bochum
Bochum, 44789
Städtisches Klinikum Braunschweig
Braunschweig, 38126
Westdeutsches Herzzentrum
Essen, 45122
Universitäres Herzzentrum Hamburg GmbH
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
Herzzentrum Leipzig
Leipzig, 04289
Deutsches Herzzentrum
Munich, 80636
Klinikum Nürnberg Süd
Nuremberg, 90471
Klinikum Oldenburg GmbH
Oldenburg, 26133
France4 sites
CHRU de Lille
Lille, 59037
CHU - Nantes
Nantes
Institut Mutualiste Montsouris
Paris, 75014
Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604
Netherlands3 sites
Academic Medical Center, Division of Cardio-thoracic Surgery
Amsterdam, 1100 DE
Catharina Ziekenhuis
Eindhoven, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, 3435
Austria2 sites
Universitäts-Klinik für Chirurgie
Graz, 8036
Universitätsklinik für Chirurgie
Vienna, 1090
Belgium2 sites
Onze-Lieve-Vrouw (OLV) Ziekenhuis
Aalst, 9300
UZ Leuven
Leuven, 3000
Switzerland1 site
Inselspital, Universitätsklinik für Herz- und Gefässchirurgie
Bern, 3010
About this study
Official title: Perceval S Valve Clinical Trial for Extended CE Mark
The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Read the detailed description
Primary Endpoints
The primary endpoint of the clinical investigation is the evaluation of the safety and effectiveness of the Perceval S valve at 12 months after implant.
The safety of Perceval valve will be assessed in terms of percentage incidence of mortality and morbidity at 12 months after implant.
The effectiveness of the Perceval s valve will be assessed in terms of:
- Improvement of clinical status by mean of New York Heart Association (NYHA) functional class at 12 months after implant
- Haemodynamic performance through echocardiography parameters as mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation at 12 months after implant
In order to determine mortality and morbidity, the following specific device related and procedure related adverse event categories will be assessed:
- valvular thrombosis, thromboembolism, hemorrhage (whether or not related to anti coagulant/ antiplatelet drug therapy) [all and major], paravalvular leak (all and major), endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation (all and valve related), explant, death (all and valve related), device dislodgement and device migration
In order to assess the Haemodynamic performance the following echocardiography parameters will be measured:
- mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation
Secondary Endpoints
The secondary endpoints of the clinical investigation are:
- Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and at 3-6 months after implant
- Evaluation of the effectiveness of Perceval S valve in terms of improvement of clinical status assessed by means of NYHA functional class at discharge (or 30 days if the patient is still hospitalized), 3-6 months after surgery
- Evaluation of the effectiveness of Perceval S valve in terms of haemodynamic performance through echocardiography at discharge (or 30 days if the patient is still hospitalized) and 3-6 months after surgery
- Mortality and morbidity as well as haemodynamic parameters will be assessed
The Protocol has been amended (CAVALIER TPS001 Rev 4.0 Nov 17, 2017) to continue the follow up of a selection of implanted patients annually up to 10 years to evaluate long term device performance in the top enroller investigational sites.
The following secondary endpoints have been added:
- Assessment of mortality and morbidity rates annually until 10 years follow up. In order to determine mortality and morbidity, the following specific device related and procedure related adverse event categories will be assessed: valvular thrombosis, thromboembolism, hemorrhage (whether or not related to anti coagulant/ antiplatelet drug therapy) [all and major], paravalvular leak, endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation, explant, death (all and valve related), device dislodgement and device migration.
- Evaluation of the effectiveness of Perceval valve in terms of improvement of clinical status assessed by NYHA change from baseline versus each follow-up up to 10 years.
- Evaluation of the effectiveness of Perceval valve in terms of haemodynamic performance through echocardiography at each follow up until 10 years. In order to assess the haemodynamic performance the following echocardiography parameters will be measured: mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation.
- Conditions
- Aortic Valve Replacement
- Being tested
- Perceval S Valve Prosthesis
- 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.
Perceval S Valve ProsthesisDevice
Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Perceval S Valve Prosthesis | Experimental | Patients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis Receives: Device: Perceval S Valve Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety: incidence of mortality
Incidence of mortality
Measured: 12 months after OP
Evaluation of the safety: Incidence of morbidity
Incidence of morbidity
Mortality and morbidity, adverse event categories: valvular thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, hemolysis, SVD, non structural dysfunction, reoperation, explant, death, device dislodgement and device migration
Measured: 12 months after OP
Evaluation of NYHA functional class
Change of NYHA functional class
Measured: 12 months after OP
Evaluation of haemodynamic performance: mean and peak gradients
Change of aortic mean gradient and peak gradient (mmHg)
Measured: 12 months after OP
Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI)
Change of EOA (cm2) and EOAI (cm2/m2) PI, cardiac output, cardiac index and degree of regurgitation
Measured: 12 months after OP
Evaluation of haemodynamic performance: Cardiac Index
Change of Cardiac Index (l/min/m2)
Measured: 12 months after OP
Evaluation of haemodynamic performance: Cardiac Output
Change of Cardiac Output (l/min)
Measured: 12 months after OP
Evaluation of haemodynamic performance: incidence and degree of regurgitation
Change of incidence (%) and degree of regurgitation (none, trace, mild, moderate, severe)
Measured: 12 months after OP
Secondary outcomes (8)
Evaluation of the safety: incidence of mortality
Incidence of mortality
Measured: 3-6 months
Evaluation of the safety: Incidence of morbidity
Incidence of morbidity
Measured: 3-6 months
Evaluation of NYHA functional class
Change of NYHA functional class
Measured: 3-6 months
Evaluation of haemodynamic performance
haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation
Measured: 3-6 months
Evaluation of the safety: Incidence of mortality
Incidence of mortality
Measured: up to 10 years
Evaluation of the safety: Incidence of morbidity
Incidence of morbidity
Measured: up to 10 years
Evaluation of NYHA functional class
Change of NYHA functional class
Measured: up to 10 years
Evaluation of haemodynamic performance
haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study start23 Feb 2010
- Primary completion31 Oct 2014
- Study completion31 Jan 2020
Why it stopped: 5 years follow up completed in October 2018, long-term follow up terminated because of low data return
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A. Haverich, Prof., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368666
- Sponsor's protocol ID
- TPS001
- Acronym
- CAVALIER
- Status last verified
- Mar 2024
- First submitted
- 7 Jun 2011
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, Cerutti E, Asch FM, Haverich A; CAVALIER Trial Investigators. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1772-1780.e11. doi: 10.1016/j.jtcvs.2020.12.109. Epub 2021 Jan 13.
PubMed 33597099
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 Trial for Extended CE Mark
- ClinicalTrials.gov ID
- NCT01368666
- Acronym / sponsor ID
- CAVALIER / TPS001
- Conditions
- Aortic Valve Replacement
- Keywords
- Aortic valve replacement, Aortic stenosis, Biological valve, Sutureless valve, Stented valve, Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 5 years follow up completed in October 2018, long-term follow up terminated because of low data return
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2010 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 8 Jun 2011 (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 primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Detailed description
Primary Endpoints
The primary endpoint of the clinical investigation is the evaluation of the safety and effectiveness of the Perceval S valve at 12 months after implant.
The safety of Perceval valve will be assessed in terms of percentage incidence of mortality and morbidity at 12 months after implant.
The effectiveness of the Perceval s valve will be assessed in terms of:
- Improvement of clinical status by mean of New York Heart Association (NYHA) functional class at 12 months after implant
- Haemodynamic performance through echocardiography parameters as mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation at 12 months after implant
In order to determine mortality and morbidity, the following specific device related and procedure related adverse event categories will be assessed:
- valvular thrombosis, thromboembolism, hemorrhage (whether or not related to anti coagulant/ antiplatelet drug therapy) [all and major], paravalvular leak (all and major), endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation (all and valve related), explant, death (all and valve related), device dislodgement and device migration
In order to assess the Haemodynamic performance the following echocardiography parameters will be measured:
- mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation
Secondary Endpoints
The secondary endpoints of the clinical investigation are:
- Assessment of mortality and morbidity rates at discharge (or 30 days if the patient is still hospitalized) and at 3-6 months after implant
- Evaluation of the effectiveness of Perceval S valve in terms of improvement of clinical status assessed by means of NYHA functional class at discharge (or 30 days if the patient is still hospitalized), 3-6 months after surgery
- Evaluation of the effectiveness of Perceval S valve in terms of haemodynamic performance through echocardiography at discharge (or 30 days if the patient is still hospitalized) and 3-6 months after surgery
- Mortality and morbidity as well as haemodynamic parameters will be assessed
The Protocol has been amended (CAVALIER TPS001 Rev 4.0 Nov 17, 2017) to continue the follow up of a selection of implanted patients annually up to 10 years to evaluate long term device performance in the top enroller investigational sites.
The following secondary endpoints have been added:
- Assessment of mortality and morbidity rates annually until 10 years follow up. In order to determine mortality and morbidity, the following specific device related and procedure related adverse event categories will be assessed: valvular thrombosis, thromboembolism, hemorrhage (whether or not related to anti coagulant/ antiplatelet drug therapy) [all and major], paravalvular leak, endocarditis, hemolysis, structural valve deterioration, non structural dysfunction, reoperation, explant, death (all and valve related), device dislodgement and device migration.
- Evaluation of the effectiveness of Perceval valve in terms of improvement of clinical status assessed by NYHA change from baseline versus each follow-up up to 10 years.
- Evaluation of the effectiveness of Perceval valve in terms of haemodynamic performance through echocardiography at each follow up until 10 years. In order to assess the haemodynamic performance the following echocardiography parameters will be measured: mean gradient and peak gradient, effective orifice area (EOA), effective orifice area indexed (EOAI), performance index, cardiac output, cardiac index and degree of regurgitation.
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 Valve Prosthesis | Experimental | Device: Perceval S Valve ProsthesisPatients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Subjects of age > 65 years;
- Subjects with aortic valve stenosis or steno-insufficiency;
- Subjects in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement with a biological prosthesis;
- Subjects willing to sign the informed consent;
- Subjects willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the Study
Key exclusion criteria (19 listed)
- Subjects involved in any other clinical study for drugs or devices;
- Subjects with a previously implanted Perceval S prosthesis, within the clinical study, that requires replacement
- Subjects with previous implantation of valve prostheses or annuloplasty ring not being replaced by the study valve
- Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass
- Subjects who require double or multiple valve replacement or repair in whom the mitral, tricuspid, or pulmonic valve would be replaced with a non-Perceval S valve or repaired
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 Valve ProsthesisReplacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis | Device | Perceval S Valve Prosthesis |
Primary outcome
Evaluation of the safety: incidence of mortality
Time frame: 12 months after OP
Incidence of mortality
Evaluation of the safety: Incidence of morbidity
Time frame: 12 months after OP
Incidence of morbidity Mortality and morbidity, adverse event categories: valvular thrombosis, thromboembolism, hemorrhage, paravalvular leak, endocarditis, hemolysis, SVD, non structural dysfunction, reoperation, explant, death, device dislodgement and device migration
Evaluation of NYHA functional class
Time frame: 12 months after OP
Change of NYHA functional class
Evaluation of haemodynamic performance: mean and peak gradients
Time frame: 12 months after OP
Change of aortic mean gradient and peak gradient (mmHg)
Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI)
Time frame: 12 months after OP
Change of EOA (cm2) and EOAI (cm2/m2) PI, cardiac output, cardiac index and degree of regurgitation
Evaluation of haemodynamic performance: Cardiac Index
Time frame: 12 months after OP
Change of Cardiac Index (l/min/m2)
Evaluation of haemodynamic performance: Cardiac Output
Time frame: 12 months after OP
Change of Cardiac Output (l/min)
Evaluation of haemodynamic performance: incidence and degree of regurgitation
Time frame: 12 months after OP
Change of incidence (%) and degree of regurgitation (none, trace, mild, moderate, severe)
8 secondary outcomes
Evaluation of the safety: incidence of mortality
Time frame: 3-6 months
Evaluation of the safety: Incidence of morbidity
Time frame: 3-6 months
Evaluation of NYHA functional class
Time frame: 3-6 months
Evaluation of haemodynamic performance
Time frame: 3-6 months
Evaluation of the safety: Incidence of mortality
Time frame: up to 10 years
Evaluation of the safety: Incidence of morbidity
Time frame: up to 10 years
Evaluation of NYHA functional class
Time frame: up to 10 years
Evaluation of haemodynamic performance
Time frame: up to 10 years
Results and safety
The study was stopped early (reason given: 5 years follow up completed in October 2018, long-term follow up terminated because of low data return). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Results publication: PubMed 33597099Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, Cerutti E, Asch FM, Haverich A; CAVALIER Trial Investigators. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1772-1780.e11. doi: 10.1016/j.jtcvs.2020.12.109. Epub 2021 Jan 13.
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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.
A. Haverich, Prof. principal investigator
Hannover Medical School
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceval S Valve Prosthesis in people with Aortic Valve Replacement, run by Corcym S.r.l at 26 sites in 8 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 5 inclusion and 19 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: stopped early, 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 26 sites in Germany, France, Netherlands, Austria, Belgium and 3 more countries. 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 was stopped early (reason given: 5 years follow up completed in October 2018, long-term follow up terminated because of low data return). 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?
Evaluation of the safety: incidence of mortality (time frame: 12 months after OP). 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?
On the ClinicalTrials.gov record for NCT01368666, which also lists 1 linked publication.
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.