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Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark (CAVALIER)

This study is currently recruiting participants.
Verified February 2012 by Sorin Group
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT01368666
First received: June 7, 2011
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Aortic Valve Replacement
 Device: Aortic valve replacement with the Perceval S prosthesis
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perceval S Valve Clinical Trial for Extended CE Mark

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Evaluation of the safety and effectiveness [ Time Frame: 12 months after OP ] [ Designated as safety issue: Yes ]

    Incidence of mortality and morbidity. Effectiveness: NYHA functional class and haemodynamic performance.

    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

    Haemodynamic performance : mean gradient and peak gradient, EOA, EOAI, PI, cardiac output, cardiac index and degree of regurgitation



Secondary Outcome Measures:
  • Safety and effectiveness [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

    The secondary endpoints of the clinical investigation are:

    • Assessment of mortality and morbidity rates at discharge and at 3-6 months after OP
    • Evaluation of the valve effectiveness in terms of improvement of clinical status assessed by means of NYHA functional class at discharge, 3-6 months after OP
    • Evaluation of the effectiveness of Perceval S valve in terms of haemodynamic performance through echocardiography at discharge and 3-6 months after surgery
    • Mortality and morbidity as well as haemodynamic parameters will be assessed


Estimated Enrollment: 300
Study Start Date: February 2010
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perceval S Valve Prosthesis
Patients who underwent replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis
 Device: Aortic valve replacement with the Perceval S prosthesis
Replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S 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
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368666

Contacts
Contact: Sara Gaggianesi, DMV +39 0161 487 481 sara.gaggianesi@sorin.com
Contact: Elisa Cerutti + 39 0161 487 201 elisa.cerutti@sorin.com

Locations
Austria
Universitäts-Klinik für Chirurgie Active, not recruiting
Graz, Austria, 8036
Universitätsklinik für Chirurgie Active, not recruiting
Wien, Austria, 1090
Belgium
Onze-Lieve-Vrouw (OLV) Ziekenhuis Active, not recruiting
Aalst, Belgium, 9300
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Bart Meuris, Professor     0032 163 442 29     bart.meuris@med.kuleuven.be    
Principal Investigator: Willem Flameng, Prof.            
France
CHRU de Lille Active, not recruiting
Lille, France, 59037
CHU - Nantes Active, not recruiting
Nantes, France
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: François Laborde, Professor     +33 1 56616510     francois.laborde@imm.fr    
Contact: Thierry Folliguet, MD     +33 1 56616510     thierry.folliguet@imm.fr    
Principal Investigator: François Laborde, Prof.            
Sub-Investigator: Thierry Folliguet, MD            
Hôpital Cardiologique du Haut-Lévêque Recruiting
Pessac, France, 33604
Contact: Xavier Roques, MD     +33 557 656 456     xavier.roques@chu-bordeaux.fr    
Contact: Francesco Madonna, MD     +33 557 656 437     francesco.madonna@chu-bordeaux.fr    
Principal Investigator: Xavier Roques, MD            
Sub-Investigator: Francesco Madonna, MD            
Germany
Herz- und Gefässzentrum Bad Bevensen Active, not recruiting
Bad Bevensen, Germany, 29549
RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH Completed
Bad Neustadt/Saale, Germany, 97616
Herz- und Diabeteszentrum NRW Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Kavous Hakim-Meibodi, MD     +49 5731 973230     khakim-meibodi@hdz-nrw.de    
Principal Investigator: Jan F. Gummert, Prof.            
Sub-Investigator: Kavous Hakim-Meibodi, MD            
Ruhr Universität Bochum Recruiting
Bochum, Germany, 44789
Contact: Matthias Bechtel, Prof.     +49-234-302-6005     Matthias.Bechtel@bergmannsheil.de    
Principal Investigator: Matthias Bechtel, Prof.            
Städtisches Klinikum Braunschweig Active, not recruiting
Braunschweig, Germany, 38126
Westdeutsches Herzzentrum Active, not recruiting
Essen, Germany, 45122
Universitäres Herzzentrum Hamburg GmbH Active, not recruiting
Hamburg, Germany, 20246
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Axel Haverich, Prof.     +49511 5326581     haverich.axel@mh-hannover.de    
Contact: Malakhlal Shrestha     +495115322157     shrestha.malakh.lal@mh-hannover.de    
Principal Investigator: Axel Haverich, Prof.            
Sub-Investigator: Malakhlal Shrestha, MD            
Herzzentrum Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Friedrich Mohr, Prof.     +49 341 8651421     mohrf@medizin.uni-leipzig.de    
Principal Investigator: Friedrich W. Mohr, Prof.            
Deutsches Herzzentrum Active, not recruiting
Munich, Germany, 80636
Klinikum Nürnberg Süd Recruiting
Nürnberg, Germany, 90471
Contact: Tatjana Lueg     +49 911 3985440     tatjana.lueg@klinikum.nuernberg.de    
Principal Investigator: Theodor Fischlein, Prof.            
Klinikum Oldenburg GmbH Active, not recruiting
Oldenburg, Germany, 26133
Netherlands
Academic Medical Center, Division of Cardio-thoracic Surgery Active, not recruiting
Amsterdam, Netherlands, 1100 DE
Catharina Ziekenhuis Active, not recruiting
Eindhoven, Netherlands, 5623 EJ
St. Antonius Ziekenhuis Active, not recruiting
Nieuwegein, Netherlands, 3435
Poland
Silesian Center for Heart Diseases Recruiting
Zabrze, Poland, 41800
Contact: Marian Zembala, Prof.     +48 32 3733689     m.zembala@sccs.pl    
Principal Investigator: Marian Zembala, Prof.            
Switzerland
Inselspital, Universitätsklinik für Herz- und Gefässchirurgie Recruiting
Bern, Switzerland, 3010
Contact: Dorothee Keller, Coordinator     +41 31 632 36 06     Dorothee.Keller@insel.ch    
Sub-Investigator: Mario Stalder, MD            
United Kingdom
Genfield General Hospital Active, not recruiting
Leicester, United Kingdom, LE39QP
Sponsors and Collaborators
Sorin Group
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT01368666     History of Changes
Other Study ID Numbers: TPS001
Study First Received: June 7, 2011
Last Updated: February 27, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information (DIMDI)
Austria: Agency for Health and Food Safety (AGES)
Switzerland: Swissmedic
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: URPL
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sorin Group:
Aortic valve replacement
Aortic stenosis
Biological valve
 Sutureless valve
Stented valve
Aortic Valve Disease

ClinicalTrials.gov processed this record on June 18, 2013