BIOVALVE - I / II Clincial Investigation (NCT02249000) | Clinical Trial Compass
CompletedNot Applicable
BIOVALVE - I / II Clincial Investigation
Belgium, Germany68 participantsStarted 2014-09
Plain-language summary
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve implantation
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. The subject is ≥65 years
✓. The subject has provided written informed consent
✓. Subject is willing to participate in the clinical investigation and to comply with all of the study procedures and follow-up visits
✓. NHYA class ≥II
✓. 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
✓. 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)
✓. Annulus diameter as determined by multi-slice computed tomography (MSCT) from 23-26 mm
Exclusion criteria
✕. Trans-esophageal echocardiogram (TEE) is contraindicated
✕. Congenital bicuspid or unicuspid valve
✕. 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
✕. Transfemoral access vessel characteristics that would preclude safe placement of a 18 French sheath
✕. Vessel and/or anatomical characteristics that would preclude safe delivery of the BIOVALVE prosthesis to the ascending aorta and/or placement of the prosthesis
✕. 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