Primary: To evaluate the safety of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.Secondary: To evaluate adverse events and study device performance.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Freedom from all-cause mortality at 30 days follow-up
Secondary outcome
Secondary:
1. Rate of major cardiac and cerebrovascular event (MACCE) at 30
days and at 12 months
2. Functional improvement from baseline as per NYHA functional
classification at 30 days and at 12 months
3. Procedural success post-implant
4. Device success at 30 days and at 12 months
Background summary
The patient will be asked to participate in the investigational study because
the patient suffers from severe aortic stenosis.
Study objective
Primary: To evaluate the safety of the study device in patients presenting with
severe aortic stenosis (AS) considered to be high risk for surgery.
Secondary: To evaluate adverse events and study device performance.
Study design
- A single arm, prospective, multicenter, non-randomized and open trial;
- 150 implanted patients at up to 15 European sites.
Intervention
-
Study burden and risks
-
Chemin de la Venoge, 11
1024 Ecublens
CH
Chemin de la Venoge, 11
1024 Ecublens
CH
Listed location countries
Age
Inclusion criteria
1. Patients 70 years of age and older
2. Additive EuroSCORE * 9
3. Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet
velocity > 4.0 m/s or aortic valve area of *1.0 cm2
4. NYHA Functional Class > II
5. Aortic annulus diameter from * 21mm up to * 27mm by TEE
6. Patient willing to participate in the study and provides signed informed consent
Exclusion criteria
1. Congenital unicuspid or bicuspid aortic valve
2. Severe eccentricity of calcification
3. Severe mitral regurgitation (> 2°)
4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring
5. Severe transapical access problem, non-reachable LV apex
6. Previous surgery of the LV using a patch, such as the Dor procedure
7. Presence of apical LV thrombus
8. ECHO evidence of intracardiac mass, thrombus, or vegetation
9. AMI within 1 month prior to the procedure
10. PCI within 1 month prior to the procedure
11. Previous TIA or stroke in the last 3 months
12. Untreated coronary artery disease (CAD) requiring revascularization
13. Hemodynamic instability: systolic pressure <90mmHg without afterload reduction,
shock, need for inotropic medication or IABP
14. LVEF < 30% by ECHO
15. Calcified pericardium
16. Septal hypertrophy unacceptable for transapical procedure
17. Primary hypertrophic obstructive cardiomyopathy (HOCM)
18. Active infection, endocarditis or pyrexia
19. Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months
20. Liver failure
21. Severe COPD requiring home oxygen
22. Blood dyscrasias: leukopenia (WBC < 3000mm3), acute anemia (Hb < 9 mg%),
thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis
or coagulopathy
23. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
24. Neurological disease severely affecting ambulation or daily functioning
25. Senile dementia
26. Another surgical or percutaneous procedure scheduled at the same time
27. Emergency procedure pre-implant
28. Life expectancy < 12 months due to non-cardiac co-morbid conditions
29. Known hypersensitivity/contraindication to study medication, contrast media, or
nitinol
30. Currently participating in an investigational drug or another device study
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | France (AFSSAPS): 2011-A00838-38 |
| CCMO | NL37774.068.11 |