Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-09

Study Completion Date

2036-12-01

Brief Summary

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

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Detailed Description

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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

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Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized 1:1

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The patient and operator cannot be blinded to allocated treatment. Most outcomes are registry based and randomization is not anticipated to impact outcome assessment.

Study Groups

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Medtronic Evolut FX

TAVI procedure performed with Medtronic Evolut FX

Group Type ACTIVE_COMPARATOR

Medtronic Evolut FX

Intervention Type DEVICE

TAVI performed with Medtronic Evolut FX

Edwards Sapien Ultra 3 Resilia

TAVI procedure performed with Edwards Sapien Ultra 3 Resilia

Group Type ACTIVE_COMPARATOR

Edwards Sapien 3 Ultra Resilia

Intervention Type DEVICE

TAVI performed with Edwards Sapien 3 Ultra Resilia

Interventions

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Medtronic Evolut FX

TAVI performed with Medtronic Evolut FX

Intervention Type DEVICE

Edwards Sapien 3 Ultra Resilia

TAVI performed with Edwards Sapien 3 Ultra Resilia

Intervention Type DEVICE

Eligibility Criteria

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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.