NL-OMON46183
Completed
Not Applicable
BIOTRONIK - Safety and clinical performance of the self-expanding transcatheter BIOVALVE prosthesis in subjects with severe symptomatic calcified aortic valve stenosis suitable for transfemoral transcatheter aortic valve implantation (TAVI) - C1205 BIOVALVE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- severe symptomatic aortic stenosis
- Sponsor
- BIOTRONIK AG
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The subject is \>\=65 years
- •2\. The subject has provided written informed consent
- •3\. Subject is willing to participate in the clinical investigation and to comply with all of the study procedures and follow\-up visits
- •4\. NHYA class \>\=II
- •5\. High surgical risk: Logistic EuroSCORE\-I \>\=20% (or equivalence of EuroSCORE\-II) or STS score \>\=10% or co\-morbidity judged by the heart team (consisting of at least one interventional cardiologist and one cardiac surgeon) to pose an absolute or relative contraindication for conventional aortic valve replacement according to VARC\-2
- •6\. Severe symptomatic calcific aortic valve stenosis characterized by mean aortic gradient \>40 mm Hg or peak jet velocity \>4\.0 m/s or effective orifice area (EOA) of \<1\.0 cm2 (\<0\.6 cm2/m2 body surface area)
- •7\. Annulus diameter as determined by multi\-slice computed tomography (MSCT) from 20\-26 mm
Exclusion Criteria
- •1\. Trans\-esophageal echocardiogram (TEE) is contraindicated
- •2\. Congenital bicuspid or unicuspid valve
- •3\. Left ventricular outflow tract (LVOT) obstruction such as hypertrophic obstructive cardio myopathy (HOCM) or subject presenting with systolic anterior motion (SAM). Evidence of intra cardiac mass, thrombus or vegetation
- •4\. Transfemoral access vessel characteristics that would preclude safe placement of a 18 French sheath
- •5\. Vessel and/or anatomical characteristics that would preclude safe delivery of the BIOVALVE prosthesis to the ascending aorta and/or placement of the prosthesis
- •6\. Anatomical restrictions such as shallow sinuses with heavily calcified leaflets, low height of coronary ostia, extreme tortuosity of the aortic arch, thoracic (TAA) or abdominal (AAA) aortic aneurysm, presence of endovascular stent graft
- •7\. Severe mitral regurgitation grade \>3
- •8\. Severe mitral stenosis
- •9\. Prosthetic mitral valve
- •10\. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%
Outcomes
Primary Outcomes
Not specified
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