Overview

This trial is active, not recruiting.

Condition aortic valve replacement
Treatment perceval s valve prosthesis
Phase phase 2/phase 3
Sponsor Sorin Group
Start date February 2010
End date October 2014
Trial size 658 participants
Trial identifier NCT01368666, TPS001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients who underwent replacement of diseased or malfunctioning native aortic valve with the Perceval S Valve prosthesis
perceval s valve prosthesis
Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis

Primary Outcomes

Measure
Evaluation of the safety and effectiveness
time frame: 12 months after OP

Secondary Outcomes

Measure
Safety and effectiveness
time frame: 3-6 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Perceval S Valve Clinical Trial for Extended CE Mark
Principal investigator A. Haverich, Prof.
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Sorin Group.