Edwards SAPIEN* Aortic Bioprothesis European Outcome Registry

Completed

Conditions: Aortic Valve Stenosis
10046973

Registration Number: NL-OMON32862

Lead Sponsor: Edwards Lifesciences Services GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

the SAPIEN* valve is indicated for use in patients with symptomatic aortic stenosis (aortic valve area <0.8cm²) requiring AVR who have high risk for operative mortality, or are *non-operable*, as determined by either or both of the
following risk assessments:
• Logistic Euro SCORE >20% or
• STS Risk score >10

Exclusion Criteria

1. Non-valvular aortic stenosis
2. Congenital aortic stenosis, unicuspid or bicuspid aortic valve
3. Non-calcific acquired aortic stenosis
4. Evidence of intracardiac mass, thrombus or vegetation
5. Untreated clinically significant coronary artery disease requiring revascularization
6. Severe deformation of the chest
7. Severe coagulation problems
8. Active bacterial endocarditis or other active infections
9. Myocardial infarction(MI) within one month
10. Unstable angina during index procedure
11. Recent pulmonary emboli
12. Recent(within 6 months) cerebrovascular accident (CVA)
13. Patients unable to tolerate anticoagulation therapy
14. Significant atheroma of femoral and iliac vessels
15. Severe tortuosities of the femoro-iliac vessels
16. Femoro-iliac vessels < 7mm
17. Patients with bilateral iliofemoral bypass
18. Hypertrophic cardiomyopathy with or without obstruction (HOCM)
19. Severe ventricular dysfunction with ejection fraction < 20%

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Collect the safety and efficacy outcomes data of the commercially available<br /><br>Edwards SAPIEN* Valve intended for the treatment of severe calcific<br /><br>degenerative aortic stenosis at discharge or <7 days, and 30 days.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Collect the safety and efficacy outcomes data of patients who received the<br /><br>commercially available Edwards SAPIEN* Valve for the treatment of severe<br /><br>calcific degenerative aortic stenosis at 1 year.</p><br>