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Clinical Trials in Denmark / NCT06470022
Active, not recruiting Not applicable

Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

NCT06470022 · tracked via the Priya Life Science Denmark tracker
Sponsor
Christian Juhl Terkelsen
Phase
Not applicable
Started
2024-08-09
Last updated
2026-08-25

Condition(s) studied

Aortic Stenosis

Investigational drug(s) / intervention(s)

Medtronic Evolut FXEdwards Sapien 3 Ultra Resilia

Medtronic Evolut FX: TAVI performed with Medtronic Evolut FX

Edwards Sapien 3 Ultra Resilia: TAVI performed with Edwards Sapien 3 Ultra Resilia

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Patient more than 18 years of age. 2. Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference. 3. The center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial. 4. The center volume should be more than 75 cases a year. 5. The patient has given signed informed consent. 6. TAVI performed via the femoral artery. Exclusion Criteria: None

Primary outcome measure(s)

  • Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration — 1-year, 3-year, 5-year, 10-year
    The primary composite endpoint is at one-year, and a non-inferiority test is performed. See separate statistical analysis plan. Separate analyses of each component of the primary outcome will be presented, in accordance with the FDA guidelines and EMA guidelines, i.e. mortality, stroke, moderate/severe aortic regurgitation and moderate/severe THV deterioration to better understand their contribution to the primary endpoint. If non-inferiority is proven for the primary composite endpoint, a split alfa is used to test for superiority if possible (alfa=0.025) and to test secondary safety and efficacy endpoints (Total alfa=0.025 for these). The composite endpoint will be re-analyzed after 3-, 5- and 10-year as superiority analyses.

Trial sites (1)

FacilityCityRegionStatus
Department of cardiology, Aarhus University Hospital Aarhus Denmark

Other trials for the same condition

Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock Recruiting
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis Recruiting
Angiotensin Receptor Blockers in Aortic Stenosis Recruiting
Quality of Life After Transcatheter Aortic Valve Implantation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06470022 on ClinicalTrials.gov ↗ ← All trials in Denmark