Abbreviations:AS (aortic stenosis), ASA (acetylsalicylic acid), AVR (aortic valve replacement), CABG (Coronary artery bypass grafting), CE (European conformity), CEC (Clinical Events Committee), CI (confidence intervals), DSMB (Data Safety Monitoring Board), EOA (effective orifice area), FDA (Food and Drug Administration), HR-QoL (health related quality of life), ICU (intensive care unit), IDE (Investigational Device Exemption), IRB (Institutional Review Board), KCCQ (Kansas City Cardiomyopathy Questionnaire), LV (Left Ventricle), LVOT (left ventricle outflow tract), NSVD (non-structural valve dysfunction), NYHA (New York Heart Association), PMI (pace-maker insertion), PVL (paravalvular leak), STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality)
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Publication stageIn Press Journal Pre-Proof
Gabriel S. Aldea: nothing to disclose
Christopher R. Burke: nothing to disclose
Theodor Fischlein: consultant CORCYM and BioStable
David A. Heimansohn: nothing to disclose
Axel Haverich: nothing to disclose
Rakesh M. Suri: nothing to disclose
Niv Ad: Atricure Inc.- Consulting; LivaNova – Consulting; Medtronic-Speaker, VGS- Advisory Board; Left Atrial Appendage Occluder LLC- Co-Founder
Funding: The CAVALIER trial and the PERCEVAL IDE Trial were funded by CORCYM S.r.l.
Clinical trial registry number: CAVALIER-NCT01368666; PERCEVAL IDE-NCT01810679
Central Picture legend: Mean aortic valve gradients over study period
Perceval valve showed low and stable gradients at 5-year follow-up with low rates of bioprosthesis degeneration and reintervention across all valve sizes.
Mid-term (5 year) clinical and echocardiographic performances of the Perceval sutureless valve was assessed prospectively using detailed Core-lab evaluations. The valve exhibited low and stable gradients, significant LV mass regression, low structural valve degeneration (VARC-3) and re-intervention rates for all valve sizes.