Perceval S valve clinical trial for extended CE-mark

Completed

Conditions: Aortic valve stenosis/insufficiency
occlusion/leakage of aortic valve
10046973

Registration Number: NL-OMON34868

Lead Sponsor: Sorin Biomedica CRM SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety endpoints:<br /><br>- Safety of the Perceval S-valve will be evaluated based on pre-determined<br /><br>adverse events related to cardiac valve replacement. Morbidity and<br /><br>valve-relatedness will be determined according to specific guidelines for<br /><br>reporting morbidity after valve surgery.<br /><br><br /><br>Effectiviness endpoints:<br /><br>Effectiviness of the Perceval S-valve will be determined by evaluation of<br /><br>hemodynamic performance to assess valve function of NYHA-classification to<br /><br>assess improvement in patient condition.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of the clinical investigation are:<br /><br>- Assessment of mortality and morbidity rates at discharge (or 30 days if the<br /><br>patient is still hospitalized) and at 3-6 months after implant;<br /><br>- Evaluation of the effectiveness of Perceval S valve in terms of improvement<br /><br>of clinical status assessed by means of NYHA-classification at discharge (or 30<br /><br>days if the patient is still hospitalized), 3-6 months after surgery;<br /><br>- Evaluation of the effectiveness of Perceval S valve in terms of haemodynamic<br /><br>performance through echocardiography at discharge (or 30<br /><br>days if the patient is still hospitalized) and 3-6 months after surgery;<br /><br>- Mortality and morbidity as well as haemodynamic parameters will be assessed.</p><br>