Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT01368666
Eligibility 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, 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01368666
Study Brief:
Protocol Section:
NCT01368666