Aortic valve stenosis/insufficiency occlusion/leakage of aortic valve
Conditions
Interventions
Beside the implantation (standard treatment) a Transthoracic echocardiography
(TTE) assessment, clinical examination (incl. NYHA-classification) and
haematological analysis will be performed during
Sponsors
Sorin Biomedica CRM SRL
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: - Safety of the Perceval S-valve will be evaluated based on pre-determined adverse events related to cardiac valve replacement. Morbidity and valve-relatedness will be determined according to specific guidelines for reporting morbidity after valve surgery. Effectiviness endpoints: Effectiviness of the Perceval S-valve will be determined by evaluation of hemodynamic performance to assess valve function of NYHA-classification to assess improvement in patient condition. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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-classification 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. | — |
Countries
Netherlands
Outcome results
None listed