A novel self-expanding transcatheter aortic valve implant, the Crea Aortic Valve (CAV) has shown promising early outcomes in a first-in-human trial involving patients with severe aortic stenosis (AS), as reported in a study published in AsiaIntervention. The minimally invasive procedure, known as transcatheter aortic valve implantation (TAVI), was assessed using Valve Academic Research Consortium (VARC)-3 criteria for device performance and safety.
The study involved three high-risk patients undergoing TAVI with the CAV system. Pre- and post-procedural assessments included computed tomography angiography and transthoracic echocardiography (TTE), with follow-up at discharge, 1 month, and 6 months to evaluate valve function and complications.
All three patients had successful CAV implantation. The key findings of the study were a reduction in maximum velocity (Vmax) to <2 m/s, a decrease in mean pressure gradient (MG) to <10 mmHg, and a trivial paravalvular leak (PVL) in all cases.
Two different implantation techniques were used, i.e., the cusp-overlap view for one patient and the coplanar view for the other two.
The study reported only one case of atrioventricular block requiring a permanent pacemaker. However, the study found no heart failure, strokes, or renal failure up to 6 months after implantation.
The results demonstrated the technical success and early safety of the CAV system.
• CAV system was tested in a first-in-human trial in 3 high-risk patients with severe AS.
• Successful implantation was achieved in all patients using two different imaging views.
• Post-TAVI, Vmax reduced to <2 m/s and MG to <10 mmHg.
• All cases showed trivial paravalvular leak (PVL)—a key marker of valve function.
• One patient required a pacemaker; no other major adverse events occurred.
• The device met VARC-3 criteria for success and safety.
• The findings support the need for future large-scale studies to further evaluate performance.
Calderas C, Taramasso M, Levy J, et al. Initial experience with the Crea Aortic Valve System - a first-in-human study. AsiaIntervention. 2025;11(1):52-59. Published 2025 Mar 20. doi:10.4244/AIJ-D-24-00023
A novel self-expanding transcatheter aortic valve implant, the Crea Aortic Valve (CAV), has shown promising early outcomes in a first-in-human trial involving patients with severe aortic stenosis (AS).