The main registry objective is to observe the safety and efficacy outcomes in patients where treatment of severe calcific degenerative aortic stenosis was intended with the commercially available Edwards SAPIEN* Valve.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Collect the safety and efficacy outcomes data of the commercially available
Edwards SAPIEN* Valve intended for the treatment of severe calcific
degenerative aortic stenosis at discharge or <7 days, and 30 days.
Secondary outcome
Collect the safety and efficacy outcomes data of patients who received the
commercially available Edwards SAPIEN* Valve for the treatment of severe
calcific degenerative aortic stenosis at 1 year.
Background summary
This registry is part of our post-marketing surveillance required by the
Notified Body. We have a limited CE mark for 1year, to prolonge our CE mark we
have to conduct this registration. The Notified Body is especially looking at
30 day mortality.
Study objective
The main registry objective is to observe the safety and efficacy outcomes in
patients where treatment of severe calcific degenerative aortic stenosis was
intended with the commercially available Edwards SAPIEN* Valve.
Study design
This is a multi-center, observational European registry. A minimum of 300
patients are to be enrolled in commercial sites. Each site will register at
least 10 patients. Patient hospitalization data should be collected from the
index procedure to discharge or <7 days post procedure (whichever comes first)
and at 30 days and 12 months post procedure.
Study burden and risks
Not Applicable
Edisonstrasse 6
85716 Unterschleissheim
Germany
Edisonstrasse 6
85716 Unterschleissheim
Germany
Listed location countries
Age
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%
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24051.058.08 |