Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. (COMPARE-TAVI)

Christian Juhl Terkelsen

Status: Enrolling

Conditions: Aortic Stenosis

Treatments: Device: Medtronic Evolut FX; Device: Edwards Sapien 3 Ultra Resilia

Study type: Interventional

Funder types: Other

Identifiers

NCT06470022

COMPARE-TAVI-2

Details and patient eligibility

About

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

Full 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).

Enrollment: 1,346 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,346 participants in 2 patient groups

Medtronic Evolut FX

Active Comparator group

Description:

TAVI procedure performed with Medtronic Evolut FX

Treatment:

Device: Medtronic Evolut FX

Edwards Sapien Ultra 3 Resilia

Active Comparator group

Description:

TAVI procedure performed with Edwards Sapien Ultra 3 Resilia

Treatment:

Device: Edwards Sapien 3 Ultra Resilia