NCT06470022

Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,346 (estimated)
• Sponsor: Christian Juhl Terkelsen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.

Detailed description

The purpose of the "Compare-TAVI" organization is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances. Purpose of present study: To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia. Hypotheses: 1. Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared. 2. There is no difference between valves in secondary safety and efficacy endpoints (see below) 3. There is no difference in Aortic Regurgitation fraction (ARF) and Effective Orifice Area (EOA) measured by CMR (CMR-substudy, N=166) 4. There is no difference in EOA measured invasively during dobutamine stress (hemodynamic substudy, N=440). 5. There is no difference in occurrence of Hypoathenuated Leaflet Thickening (HALT) measured by CT (CT-substudy, N=778).

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic Evolut FX	TAVI performed with Medtronic Evolut FX
DEVICE	Edwards Sapien 3 Ultra Resilia	TAVI performed with Edwards Sapien 3 Ultra Resilia

Timeline

• Start date: 2024-08-09
• Primary completion: 2025-12-01
• Completion: 2036-12-01
• First posted: 2024-06-24
• Last updated: 2025-03-11

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study