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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01368666
Other study ID # TPS001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 23, 2010
Est. completion date January 31, 2020

Study information

Verified date March 2024
Source Corcym S.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 658
Est. completion date January 31, 2020
Est. primary completion date October 31, 2014
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Subjects of age > 65 years; 2. Subjects with aortic valve stenosis or steno-insufficiency; 3. Subjects in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement with a biological prosthesis; 4. Subjects willing to sign the informed consent; 5. Subjects willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the Study Exclusion Criteria: 1. Subjects involved in any other clinical study for drugs or devices; 2. Subjects with a previously implanted Perceval S prosthesis, within the clinical study, that requires replacement 3. Subjects with previous implantation of valve prostheses or annuloplasty ring not being replaced by the study valve 4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass 5. 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 6. Subjects with aneurysmal dilation or dissection of the ascending aortic wall 7. Subjects needing non elective intervention 8. Subjects with active endocarditis 9. Subjects with active myocarditis 10. Subjects with congenital bicuspid aortic valve 11. 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) 12. 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 13. Subjects with myocardial infarction < 90 days before the planned valve implant surgery 14. Subjects with known hypersensitivity to nickel alloys 15. The subject has a documented history of substance (drug or alcohol) abuse 16. The subject is a prison inmate, institutionalized, or is unable to give informed consent; 17. 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 18. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism 19. 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Perceval S Valve Prosthesis
Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis

Locations

Country Name City State
Austria Universitäts-Klinik für Chirurgie Graz
Austria Universitätsklinik für Chirurgie Wien
Belgium Onze-Lieve-Vrouw (OLV) Ziekenhuis Aalst
Belgium UZ Leuven Leuven
France CHRU de Lille Lille
France CHU - Nantes Nantes
France Institut Mutualiste Montsouris Paris
France Hôpital Cardiologique du Haut-Lévêque Pessac
Germany Herz- und Gefässzentrum Bad Bevensen Bad Bevensen
Germany RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH Bad Neustadt An Der Saale
Germany Herz- und Diabeteszentrum NRW Bad Oeynhausen
Germany Ruhr Universität Bochum Bochum
Germany Städtisches Klinikum Braunschweig Braunschweig
Germany Westdeutsches Herzzentrum Essen
Germany Universitäres Herzzentrum Hamburg GmbH Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Herzzentrum Leipzig Leipzig
Germany Deutsches Herzzentrum Munich
Germany Klinikum Nürnberg Süd Nürnberg
Germany Klinikum Oldenburg GmbH Oldenburg
Netherlands Academic Medical Center, Division of Cardio-thoracic Surgery Amsterdam
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands St. Antonius Ziekenhuis Nieuwegein
Poland Silesian Center for Heart Diseases Zabrze
Switzerland Inselspital, Universitätsklinik für Herz- und Gefässchirurgie Bern
United Kingdom Genfield General Hospital Leicester

Sponsors (1)

Lead Sponsor Collaborator
Corcym S.r.l

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Netherlands,  Poland,  Switzerland,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the safety: incidence of mortality Incidence of mortality 12 months after OP
Primary 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
12 months after OP
Primary Evaluation of NYHA functional class Change of NYHA functional class 12 months after OP
Primary Evaluation of haemodynamic performance: mean and peak gradients Change of aortic mean gradient and peak gradient (mmHg) 12 months after OP
Primary 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 12 months after OP
Primary Evaluation of haemodynamic performance: Cardiac Index Change of Cardiac Index (l/min/m2) 12 months after OP
Primary Evaluation of haemodynamic performance: Cardiac Output Change of Cardiac Output (l/min) 12 months after OP
Primary Evaluation of haemodynamic performance: incidence and degree of regurgitation Change of incidence (%) and degree of regurgitation (none, trace, mild, moderate, severe) 12 months after OP
Secondary Evaluation of the safety: incidence of mortality Incidence of mortality 3-6 months
Secondary Evaluation of the safety: Incidence of morbidity Incidence of morbidity 3-6 months
Secondary Evaluation of NYHA functional class Change of NYHA functional class 3-6 months
Secondary Evaluation of haemodynamic performance haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation 3-6 months
Secondary Evaluation of the safety: Incidence of mortality Incidence of mortality up to 10 years
Secondary Evaluation of the safety: Incidence of morbidity Incidence of morbidity up to 10 years
Secondary Evaluation of NYHA functional class Change of NYHA functional class up to 10 years
Secondary Evaluation of haemodynamic performance haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation up to 10 years
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