Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06470022

Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Led by Christian Juhl Terkelsen · Updated on 2026-04-28

1346

Participants Needed

1

Research Sites

642 weeks

Total Duration

On this page

Sponsors

C

Christian Juhl Terkelsen

Lead Sponsor

D

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient more than 18 years of age.
  • Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference.
  • 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.
  • The center volume should be more than 75 cases a year.
  • The patient has given signed informed consent.
  • TAVI performed via the femoral artery.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of cardiology, Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

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Research Team

C

Christian J Terkelsen, Professor

CONTACT

H

Helle Bargsteen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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