NL-OMON34868
Completed
Not Applicable
Perceval S valve clinical trial for extended CE-mark - CAVALIER study
Sorin Biomedica CRM SR0 sites45 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic valve stenosis/insufficiency
- Sponsor
- Sorin Biomedica CRM SR
- Enrollment
- 45
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects of age 65 (or older) 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;
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;
- •Subjects with aneurysmal dilation or dissection of the ascending aortic wall;
- •Subjects with active endocarditis, myocarditis;
- •Subjects with congenital bicuspid aortic valve;
- •Subjects with myocardial infarction \< 90 days before the planned valve implant surgery;
- •Subjects with known hypersensitivity to nickel alloys.
Outcomes
Primary Outcomes
Not specified
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