Clinical trial NCT01368666: Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark
Official title: Perceval S Valve Clinical Trial for Extended CE Mark
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Replacement
Keywords: Aortic valve replacement
Aortic stenosis
Biological valve
Sutureless valve
Stented valve
Aortic Valve Disease
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 658
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the safety: incidence of mortality
timeFrame: 12 months after OP
measure: Evaluation of the safety: Incidence of morbidity
timeFrame: 12 months after OP
measure: Evaluation of NYHA functional class
timeFrame: 12 months after OP
measure: Evaluation of haemodynamic performance: mean and peak gradients
timeFrame: 12 months after OP
measure: Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI)
timeFrame: 12 months after OP
measure: Evaluation of haemodynamic performance: Cardiac Index
timeFrame: 12 months after OP
measure: Evaluation of haemodynamic performance: Cardiac Output
timeFrame: 12 months after OP
measure: Evaluation of haemodynamic performance: incidence and degree of regurgitation
timeFrame: 12 months after OP
Secondary outcomes:
measure: Evaluation of the safety: incidence of mortality
timeFrame: 3-6 months
measure: Evaluation of the safety: Incidence of morbidity
timeFrame: 3-6 months
measure: Evaluation of NYHA functional class
timeFrame: 3-6 months
measure: Evaluation of haemodynamic performance
timeFrame: 3-6 months
measure: Evaluation of the safety: Incidence of mortality
timeFrame: up to 10 years
measure: Evaluation of the safety: Incidence of morbidity
timeFrame: up to 10 years
measure: Evaluation of NYHA functional class
timeFrame: up to 10 years
measure: Evaluation of haemodynamic performance
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitäts-Klinik für Chirurgie
city: Wien
country: Austria
facility: Universitätsklinik für Chirurgie
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouw (OLV) Ziekenhuis
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lille
country: France
facility: CHRU de Lille
city: Nantes
country: France
facility: CHU - Nantes
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut-Lévêque
city: Bad Bevensen
country: Germany
facility: Herz- und Gefässzentrum Bad Bevensen
city: Bad Neustadt An Der Saale
country: Germany
facility: RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Bochum
country: Germany
facility: Ruhr Universität Bochum
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Munich
country: Germany
facility: Deutsches Herzzentrum
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg GmbH
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, Division of Cardio-thoracic Surgery
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
city: Bern
country: Switzerland
facility: Inselspital, Universitätsklinik für Herz- und Gefässchirurgie
city: Leicester
country: United Kingdom
facility: Genfield General Hospital
Study officials:
affiliation: Hannover Medical School
name: A. Haverich, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.