NCT07506382

Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 419 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott)

Detailed description

Compared with balloon-expandable valves, self-expandable supra annular devices (Mertronic Evolut) offer superior post-procedural hemodynamics in TAVR and are, therefore, expected to play a growing role in clinical practice particularly in small aortic anatomies . However, the relatively long stent frame of self-expandable valves posed challenges for coronary access after implantation and PPI rates remain higher, despite lower implantation height with the cusp overlap technique The Navitor valves (Abbott Structural Valve) is a new generation intra-annular self-expandable device with tall stent frame but larger stent cells and shorter outer skirt which may be more favorable for future coronary access than the Evolut FX valves, particularly in patients with lower coronary heights . The Navitor platform showed satisfying data in tricuspid anatomy, providing intra-annular leaflets, an innovative sealing cuff, and repositionability .However this platform showed a high rate of PPI that could be related to the need for lower implantation to stabilize the device (first generation) Considering the lack of specific data regarding the compared performance of the 2 plateforms including latest generation devices, we aimed to evaluate procedural success, clinical and hemodynamic results, and conductive disorders between the 2 platforms in an observational real life study

Conditions

• Trans-catheter Aortic Valve Implantation

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-02-15
• Completion: 2028-03-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: France