- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368666
Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark (CAVALIER)
Perceval S Valve Clinical Trial for Extended CE Mark
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Graz, Austria, 8036
- Universitäts-Klinik für Chirurgie
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Wien, Austria, 1090
- Universitätsklinik für Chirurgie
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Aalst, Belgium, 9300
- Onze-Lieve-Vrouw (OLV) Ziekenhuis
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Leuven, Belgium, 3000
- UZ Leuven
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Lille, France, 59037
- CHRU de Lille
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Nantes, France
- CHU - Nantes
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Paris, France, 75014
- Institut Mutualiste Montsouris
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Pessac, France, 33604
- Hôpital Cardiologique Du Haut-Lévêque
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Bad Bevensen, Germany, 29549
- Herz- und Gefässzentrum Bad Bevensen
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Bad Neustadt An Der Saale, Germany, 97616
- RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH
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Bad Oeynhausen, Germany, 32545
- Herz- und Diabeteszentrum NRW
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Bochum, Germany, 44789
- Ruhr Universitat Bochum
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Braunschweig, Germany, 38126
- Städtisches Klinikum Braunschweig
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Essen, Germany, 45122
- Westdeutsches Herzzentrum
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Hamburg, Germany, 20246
- Universitäres Herzzentrum Hamburg GmbH
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover
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Leipzig, Germany, 04289
- Herzzentrum Leipzig
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Munich, Germany, 80636
- Deutsches Herzzentrum
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Nürnberg, Germany, 90471
- Klinikum Nürnberg Süd
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Oldenburg, Germany, 26133
- Klinikum Oldenburg GmbH
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Amsterdam, Netherlands, 1100 DE
- Academic Medical Center, Division of Cardio-thoracic Surgery
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Eindhoven, Netherlands, 5623 EJ
- Catharina Ziekenhuis
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Nieuwegein, Netherlands, 3435
- St. Antonius Ziekenhuis
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Zabrze, Poland, 41800
- Silesian Center for Heart Diseases
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Bern, Switzerland, 3010
- Inselspital, Universitätsklinik für Herz- und Gefässchirurgie
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Leicester, United Kingdom, LE39QP
- Genfield General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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, 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perceval S Valve Prosthesis
Patients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis
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Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the safety: incidence of mortality
Time Frame: 12 months after OP
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Incidence of mortality
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12 months after OP
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Evaluation of the safety: Incidence of morbidity
Time Frame: 12 months after OP
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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
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Evaluation of NYHA functional class
Time Frame: 12 months after OP
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Change of NYHA functional class
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12 months after OP
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Evaluation of haemodynamic performance: mean and peak gradients
Time Frame: 12 months after OP
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Change of aortic mean gradient and peak gradient (mmHg)
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12 months after OP
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Evaluation of haemodynamic performance: Effective Orifice Area (EOA) and Effective Orifice Area indexed (EOAI)
Time Frame: 12 months after OP
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Change of EOA (cm2) and EOAI (cm2/m2) PI, cardiac output, cardiac index and degree of regurgitation
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12 months after OP
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Evaluation of haemodynamic performance: Cardiac Index
Time Frame: 12 months after OP
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Change of Cardiac Index (l/min/m2)
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12 months after OP
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Evaluation of haemodynamic performance: Cardiac Output
Time Frame: 12 months after OP
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Change of Cardiac Output (l/min)
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12 months after OP
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Evaluation of haemodynamic performance: incidence and degree of regurgitation
Time Frame: 12 months after OP
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Change of incidence (%) and degree of regurgitation (none, trace, mild, moderate, severe)
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12 months after OP
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the safety: incidence of mortality
Time Frame: 3-6 months
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Incidence of mortality
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3-6 months
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Evaluation of the safety: Incidence of morbidity
Time Frame: 3-6 months
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Incidence of morbidity
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3-6 months
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Evaluation of NYHA functional class
Time Frame: 3-6 months
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Change of NYHA functional class
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3-6 months
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Evaluation of haemodynamic performance
Time Frame: 3-6 months
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haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation
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3-6 months
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Evaluation of the safety: Incidence of mortality
Time Frame: up to 10 years
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Incidence of mortality
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up to 10 years
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Evaluation of the safety: Incidence of morbidity
Time Frame: up to 10 years
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Incidence of morbidity
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up to 10 years
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Evaluation of NYHA functional class
Time Frame: up to 10 years
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Change of NYHA functional class
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up to 10 years
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Evaluation of haemodynamic performance
Time Frame: up to 10 years
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haemodynamic performance: mean gradient and peak gradient, EOA, EOAI, cardiac output, cardiac index and degree of regurgitation
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up to 10 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: A. Haverich, Prof., Hannover Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TPS001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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