Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark (CAVALIER)
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| ClinicalTrials.gov Identifier: NCT01368666 |
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Recruitment Status : Unknown
Verified May 2015 by LivaNova.
Recruitment status was: Active, not recruiting
First Posted : June 8, 2011
Last Update Posted : May 22, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aortic Valve Replacement | Device: Perceval S Valve Prosthesis | Phase 2 Phase 3 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 658 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Perceval S Valve Clinical Trial for Extended CE Mark |
| Study Start Date : | February 2010 |
| Actual Primary Completion Date : | October 2014 |
| Estimated Study Completion Date : | September 2018 |
| Arm | Intervention/treatment |
|---|---|
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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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Device: Perceval S Valve Prosthesis
Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis |
- Evaluation of the safety and effectiveness [ Time Frame: 12 months after OP ]
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
- Safety and effectiveness [ Time Frame: 3-6 months ]
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368666
Show 26 study locations
| Principal Investigator: | A. Haverich, Prof. | Hannover Medical School |
| Responsible Party: | LivaNova |
| ClinicalTrials.gov Identifier: | NCT01368666 |
| Other Study ID Numbers: |
TPS001 |
| First Posted: | June 8, 2011 Key Record Dates |
| Last Update Posted: | May 22, 2015 |
| Last Verified: | May 2015 |
|
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