Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medtronic Evolut FX, Edwards Sapien 3 Ultra Resilia.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
Overview
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Detailed 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).
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
Primary outcome measures
- Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration [Time frame: 1-year, 3-year, 5-year, 10-year]
Secondary outcome measures (12)
- TAVI-related complications [Time frame: 7-days]
- Proportion with successful implantation of the chosen valve. [Time frame: 7-days]
- SMART criteria for bioprosthetic valve dysfunction through 12 months [Time frame: 1-year]
- Pacemaker-implantation [Time frame: 1-year]
- Vascular and access-related complications (exploratory only) [Time frame: 30-days]
- Bleeding and transfusion (exploratory only) [Time frame: 30-days]
- Endocarditis (exploratory only) [Time frame: 30-day, 1-year, 3-year, 5-year, 10-year]
- Reoperation (exploratory only) [Time frame: 30-day, 1-year, 3-year, 5-year, 10-year]
- Moderate/severe prosthesis-patient mismatch (exploratory only) [Time frame: 30-day]
- Mean gradient (exploratory only) [Time frame: 30-day, 1-year, 3-year, 5-year, 10-year]
- Pacemaker-implantation (exploratory only) [Time frame: 30-day prior to TAVI, 30-day, 1-year, 3-year, 5-year, 10-year]
- Readmission for congestive heart failure (exploratory only) [Time frame: 30-day, 1-year, 3-year, 5-year, 10-year.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Department of cardiology, Aarhus University Hospital — Aarhus
Publications
- Thim T, Nissen H, Niemela M, Eftekhari A, Jalanko M, Savontaus M, Jaaskelainen P, Hensey M, Jensen RV, Norgaard BL, Frederiksen CA, Vase HO, Pedersen L, Sorensen HT, Christiansen EH, Terkelsen CJ. Design and rationale of the COMPARE-TAVI 2 trial: An all-comers head-to-head comparison of Evolut FX+ and Sapien 3 Ultra Resilia transcatheter heart valves. Am Heart J. 2026 Jul;297:107387. doi: 10.1016/ PMID 41740661
Identifiers
NCT: NCT06470022 · COMPARE-TAVI-2