DRKS00013491
Completed
Phase 3
ACURATE TF Transfemoral Aortic Bioprosthesis for Implantation in patients with severe aortic stenosis - ACURATE TF 2013-01
Symetis SA0 sites39 target enrollmentFebruary 9, 2018
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- I35.0
- Sponsor
- Symetis SA
- Enrollment
- 39
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient 75 years of age and older
- •2\. Severe aortic stenosis defined as:
- •o Mean aortic gradient \> 40 mmHg or
- •o Peak jet velocity \> 4\.0 m/s or
- •o Aortic valve area of \< 1\.0 cm2
- •3\. High risk candidate for conventional AVR defined as:
- •o Logistic EuroSCORE 1 \= 20 or
- •o Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co\-morbid conditions unrelated to aortic stenosis
- •4\. NYHA Functional Class \> II
- •5\. Aortic annulus diameter from \= 21mm up to \= 27mm by CT or TEE
Exclusion Criteria
- •1\. Unicuspid or bicuspid aortic valve
- •2\. Extreme eccentricity of calcification
- •3\. Severe mitral regurgitation (\>2\+)
- •4\. Pre\-existing prosthetic heart valve in any position and / or prosthetic ring
- •5\. Aortic or peripheral anatomy NOT appropriate for transfemoral implant
- •6\. Thoracic (TAA) or abdominal (AAA) aortic aneurysm
- •7\. Presence of endovascular stent graft for treatment of TAA or AAA
- •8\. Trans\-esophageal echocardiogram (TEE) is contraindicated
- •9\. ECHO evidence of intracardiac mass, thrombus, or vegetation
- •10\. LVEF \< 30% by ECHO
Outcomes
Primary Outcomes
Not specified
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