NCT04443023

Brief Summary

The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,031

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2025

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

June 7, 2020

Last Update Submit

April 22, 2026

Conditions

Transcatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with MACE (Major Adverse Cardiovascular Events)

    Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria

    1 year

Secondary Outcomes (26)

  • Percentage of patients with MACE

    30 day, 3-year, 5-year and 10-year

  • Percentage death

    30-day, 1-year, 3-year, 5-year, 10-year

  • Percentage of patients with stroke

    During admission, 30-day, 1-year, 3-year, 5-year, 10-year

  • Percentage of patients with moderate or severe paravalvular leakage

    30-day, 1-year, 3-year, 5-year, 10-year

  • Percentage of patients with moderate/major aortic stenosis

    30-day, 1-year, 3-year, 5-year, 10-year

  • +21 more secondary outcomes

Study Arms (2)

Sapien

ACTIVE COMPARATOR

Patients randomized to treatment

Device: chosen TAVI valve

Myval

ACTIVE COMPARATOR

Patients randomized to treatment

Device: chosen TAVI valve

Interventions

chosen TAVI valveDEVICE

chosen TAVI valve

MyvalSapien

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient more than 18 years of age.
  • Patient eligible for at least 2 valves being implanted routinely at the participating center, 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 at least 15 valves implanted before a valve can be 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:

  • \. Not able to give written inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (2)

  • Terkelsen CJ, Thim T, Freeman P, Dahl JS, Norgaard BL, Kim WY, Tang M, Sorensen HT, Christiansen EH, Nissen H. Randomized comparison of TAVI valves: The Compare-TAVI trial. Am Heart J. 2024 Aug;274:84-94. doi: 10.1016/j.ahj.2024.05.003. Epub 2024 May 9.

    PMID: 38729550BACKGROUND

  • Terkelsen CJ, Freeman P, Dahl JS, Thim T, Norgaard BL, Mogensen NSB, Tang M, Eftekhari A, Povlsen JA, Poulsen SH, Pedersen L, Hjort J, Ellert J, Christiansen EH, Sorensen HT, Nissen H. SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial. Lancet. 2025 Apr 19;405(10487):1362-1372. doi: 10.1016/S0140-6736(25)00106-0. Epub 2025 Apr 2. Erratum In: Lancet. 2025 Jun 21;405(10496):2204. doi: 10.1016/S0140-6736(25)01251-6. Lancet. 2026 Feb 21;407(10530):762. doi: 10.1016/S0140-6736(26)00315-6.

    PMID: 40187364DERIVED

Study Officials

  • henrik nissen, PhD

    odense univeristy hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 23, 2020

Study Start

June 15, 2020

Primary Completion

November 2, 2023

Study Completion

November 2, 2025

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Normally this will be possible when data are published and anonymized. Mainly to support meta-analysis on individual level data.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
When endpoints are published in an international peer-reviewed paper
Access Criteria
To share data there shall be a well-defined purpose. This could be to contribute to a meta-analysis on individual level data.

Locations

DK(1)