Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

NCT06470022 | Recruiting DMC FDA Device

• 1 other identifier: COMPARE-TAVI-2
• Study Type: interventional
• Target: 1,346
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Stenosis

Outcome Measures

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.

  1-year, 3-year, 5-year, 10-year

Secondary Outcomes (16)

• TAVI-related complications

  7-days

• Proportion with successful implantation of the chosen valve.

  7-days

• SMART criteria for bioprosthetic valve dysfunction through 12 months

  1-year

• Pacemaker-implantation

  1-year

• Vascular and access-related complications (exploratory only)

  30-days

Study Arms (2)

Medtronic Evolut FX

ACTIVE COMPARATOR

TAVI procedure performed with Medtronic Evolut FX

Device: Medtronic Evolut FX

Edwards Sapien Ultra 3 Resilia

ACTIVE COMPARATOR

TAVI procedure performed with Edwards Sapien Ultra 3 Resilia

Device: Edwards Sapien 3 Ultra Resilia

Interventions

Medtronic Evolut FX DEVICE

TAVI performed with Medtronic Evolut FX

Medtronic Evolut FX

Edwards Sapien 3 Ultra Resilia DEVICE

TAVI performed with Edwards Sapien 3 Ultra Resilia

Edwards Sapien Ultra 3 Resilia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Christian Juhl Terkelsen: lead
• Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark: collaborator

Study Sites (1)

Department of cardiology, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Related Publications (1)

• 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 Feb 23;297:107387. doi: 10.1016/j.ahj.2026.107387. Online ahead of print.

  PMID: 41740661 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• christian J Terkelsen, Professor

  Department of cardiology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian J Terkelsen, Professor

CONTACT

+4540135388; CHRITERK@RM.DK

Helle Bargsteen

CONTACT

+4578452112; hellbarg@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The patient and operator cannot be blinded to allocated treatment. Most outcomes are registry based and randomization is not anticipated to impact outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DmSc, PhD

Model Details: Randomized 1:1

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2036
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available now. Analytic will be made available when final statistical analyses performed.
• Access Criteria: Contact primary investigator

Locations

DK (1)