Aortic stenosis (AS) represents the most prevalent acquired valvular heart disease in European populations, and transcatheter aortic valve implantation (TAVI) has become the dominant treatment modality for patients with symptomatic severe AS. The latest 2025 ESC guidelines have broadened age-related eligibility, while the procedure still continues to be limited to centres with cardiac surgery on-site (CSOS). This limitation is in place, despite the very low rate of complications requiring emergent surgical conversion. This subsequently, may constrain procedural capacity and contribute to prolonged waiting times, which in turn are associated with increased pre-procedural mortality and heart failure-related hospitalizations. This prospective randomized open-label clinical trial aims to evaluate the safety and feasibility of performing TAVI in selected pilot centers operating without on-site cardiac surgery department (no-CSOS). Selected patients with severe native AS deemed suitable for transfemoral TAVI by a Heart Team will be enrolled. No-CSOS centers must meet predefined criteria, including operators experience, hybrid operating room availability, on-site vascular surgery availability, and established rapid transfer pathways to CSOS centers. The primary endpoint of the study is early 30-day safety based on VARC-3 criteria; secondary endpoints include additional composite outcomes. Patients will be randomly assigned in a 1:1 ratio using a central Web-based system to undergo TAVI either at a CSOS or non-CSOS site. A total of 404 patients (202 per group) is required. The study will inform national strategies and contribute to defining contemporary safety standards for TAVI delivery in no-CSOS centres.
Severe degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥40 mmHg or jet velocity ≥4.0 m/s or an aortic valve area (AVA) of ≤1 cm2 (or AVA index <0.6 cm2/m2)
Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II.
Suitable for percutaneous transfemoral access
Age ≥70 years
Prior aortic valve replacement
Bicuspid aortic valve on pre-procedural CT
Contraindication to femoral access
Other imaging features indicating increased procedural risk (extremely horizontal aorta, severe aortic root dilatation, aortic annulus outside the range of commercially available devices, high coronary risk occlusion)
Parallel
transcathter aortic valve implantation
Procedure/SurgeryPatients with severe native AS who are adjudicated as suitable candidates for transfemoral TAVI by the Heart Team in CSOS centre will be eligible for inclusion in the study. The choice of the transcatheter heart valve will be at the discrection of the local heart team (all available THV's will be allowed). Major anatomical contraindications to inclusion in the trial will include previous aortic valve implantation, native bicuspid aortic valve morphology and CT-derived imaging characteristics indicative of a high risk of access-site and delivery route complications.
Early safety
absence of: (i) all-cause mortality; (ii) stroke; (iii) VARC type 2-4 bleeding; (iv) major vascular or access-related complications; (v) cardiac structural complications; (vi) acute kidney injury stage 3-4; (vii) moderate or severe aortic regurgitation; (viii) new permanent pacemaker implantation; and (ix) device-related surgery or intervention.
Device success
successful deployment, correct positioning, no urgent surgery
clinical efficacy
freedom from all-cause mortality, all stroke, hospitalization for valve/procedure-related causes, and unfavorable patient-reported quality of life
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