MedTrace Logo

Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

NCT06470022 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1346

Last updated 2026-04-28

No results posted yet for this study

Summary

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

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Medtronic Evolut FX

TAVI performed with Medtronic Evolut FX

DEVICE

Edwards Sapien 3 Ultra Resilia

TAVI performed with Edwards Sapien 3 Ultra Resilia

Sponsors & Collaborators

  • Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark

    collaborator UNKNOWN

  • Christian Juhl Terkelsen

    lead OTHER

Principal Investigators

  • christian J Terkelsen, Professor · Department of cardiology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2026-07-01
Completion
2036-12-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06470022 on ClinicalTrials.gov