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:
Sorin Group
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
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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:
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:
- 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
Exclusion Criteria:
- 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
- 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
- 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
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 17, 2013