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Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChristian Juhl Terkelsen

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medtronic Evolut FX

    Device

    TAVI performed with Medtronic Evolut FX

  • Edwards Sapien 3 Ultra Resilia

    Device

    TAVI performed with Edwards Sapien 3 Ultra Resilia

Treatment groups

1,346 Participants
are divided into 2 treatment groups
Group A: Medtronic Evolut FXActive comparator 1 intervention
Group B: Edwards Sapien Ultra 3 ResiliaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration

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.

Time frame
1-year, 3-year, 5-year, 10-year

Secondary outcomes

1

TAVI-related complications

conversion to open surgery during implantation, unplanned use of cardiopulmonary support (CPS), coronary artery obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade / pericardial effusion resulting in pericardiocentesis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria 10, or annulus rupture, aortic rupture/perforation, aortic dissection, or other shunts than VSD.

Time frame
7-days
2

Proportion with successful implantation of the chosen valve.

This means no need for more than 1 TAVI valve, no change to another valve than planned during the procedure because it was impossible to implant the valve planned, and no conversion to surgery or procedure-related death.

Time frame
7-days
3

SMART criteria for bioprosthetic valve dysfunction through 12 months

composed of the following components: (1) hemodynamic structural valve dysfunction, defined as aortic valve mean gradient ≥ 20 mmHg at any time up to the 12-month visit echo; (2) nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or ≥ moderate total aortic regurgitation at any time up to the 12-month visit echo; (3) clinical valve thrombosis; (4) endocarditis; or (5) aortic valve reintervention.

Time frame
1-year
4

Pacemaker-implantation

New pace-maker implantation in pacemaker-naive patients.

Time frame
1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christian Juhl Terkelsen

Lead sponsor

Aarhus University Hospital Skejby

Sponsor institution

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

Collaborator

Source ClinicalTrials.gov
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