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Completed

NCT Number: NCT04443023

Comparison of Eligible TAVI-valves - Cohort B

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

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Key information

Conditions

Transcatheter Aortic Valve Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.

Purpose: To randomize between two TAVI-valve types in patients who according to a heart team conference is found eligible for treatment with more than one valve.

Hypotheses:

  • There is no difference in the combined endpoint (death, stroke, moderate/severe para-valvular leakage, moderate/severe device stenosis) between the two valves to be compared.
  • There is no difference between valves in secondary endpoints: death, stroke, moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.

Design: Randomized controlled trial with clinical national registry follow-up.

Centers eligible for inclusion: Scandinavian and European centers who fulfill the above mentioned criteria.

Randomization:

Before randomizing patients, the center decides which two valves the patient is found eligible for, and enters these valves in the electronic randomization form (TrialPartner). Randomization is then performed between these two valves. A patient is only randomized if a dedicated technical TAVI conference has found the patient eligible for treatment with both valves.

Consecutive cohorts are established.

In the current study we plan to initiate the following cohorts:

Cohort B: Patients randomized to the Sapien or the Myval TAVI valve.

Operator requirements:

Any procedure requires that the physician has performed at least 15 implantations with the valve in use. Otherwise the procedure is performed according to the routine of the institution.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Not able to give written inform consent

Treatment and study plan

chosen TAVI valve

Device

chosen TAVI valve

Primary outcomes

  1. Percentage of patients with MACE (Major Adverse Cardiovascular Events)

    Time frame: 1 year

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

Secondary outcomes

  1. Percentage of patients with MACE

    Time frame: 30 day, 3-year, 5-year and 10-year

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

  2. Percentage death

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    Mortality

  3. Percentage of patients with stroke

    Time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year

    According to Valve Academic Research Consortium (VARC)-3 criteria

  4. Percentage of patients with moderate or severe paravalvular leakage

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    Moderate or severe paravalvular leakage according to VARC-3 criteria

  5. Percentage of patients with moderate/major aortic stenosis

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    According to VARC-3 criteria

  6. Percentage of patients with new pacemaker

    Time frame: During admission, 30-day, 1-year, 3-year, 5-year, 10-year

    New Pacemaker after TAVI-procedure

  7. Percentage of patients with major bleeding

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    Major bleeding according to Bleeding Academic Research Consortium (BARC) type 3 or 5 criteria, resulting in either a drop in Hbg>=1.86 mmol/l or >=2 units of blood transfusion

  8. Distance in meters during 6-minute walk test

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    6-minute walk test

  9. Percentage of patients with other TAVI-related complications

    Time frame: During TAVI-procedure

    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, valve thrombosis, valve embolization, valve migration, need for TAVI-in-TAVI deployment, using VARC-3 criteria

  10. Percentage of patients with endocarditis

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    Endocarditis

  11. Proportion with successful implantation of the chosen valve.

    Time frame: During procedure

    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.

  12. Percentage of patients with major vascular access site and access-related complications

    Time frame: During admission and 30-day

    According to VARC-3 criteria

  13. Percentage of patients with valve thrombosis or severe stenosis

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    Valve thrombosis or severe stenosis confirmed by Echo or HCT

  14. Percentage of patients with readmission with congestive heart failure

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    Readmission with congestive heart failure

  15. Percentage of patients with increase in creatinin level of 100% or more, or dialysis

    Time frame: during admission and within 30 days

    Increase in renal creatinine level more than to >=200% (AKIN stage 2-3, VARC-3 criteria) or dialysis

  16. Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups

    Time frame: 30-day

    Severity of PVL stratified according to level of annular calcium on HCT (low/medium/high)

  17. Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups

    Time frame: 30-day

    Gradient (AO) stratified according to level of annular calcium on HCT (low/medium/high)

  18. Percentage of patients with prosthesis-patient mismatch

    Time frame: 30-day, 1-year, 3-year, 5-year, 10-year

    Prosthesis-patient mismatch (EOA/body surface area). Severe PPM≤0.65 cm2/m2. Moderate PPM≤0.85 cm2/m2 according to VARC-3 criteria

  19. Mean effective orifice area measured by MRI

    Time frame: 30-day

    Effective orifice area measured by MRI in patients participating in MRI-substudy

  20. Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT

    Time frame: 30-day and 1-year

    Leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT in patients participating in HCT-substudy

  21. Mean volume of aortic regurgitation measured by MRI

    Time frame: 30-day

    Volume of aortic regurgitation measured by MRI in patients participating in MRI-substudy

  22. Other tavi-related complications

    Time frame: 30-day

    Anulus rupture or aortic rupture

  23. AMI

    Time frame: 30-day, 1-year, 3-year, 5-year and 10-year

    Acute Myocardial Infarction

  24. PCI og CABG

    Time frame: 30-day, 1-year, 3-year, 5-year and 10-year

    Percutaneous Coronary Intervention or coronary artery bypass grafting

  25. Reopeation

    Time frame: 30-day, 1-year, 3-year, 5-year and 10-year

    Reopeation with TAVI, Surgical ortic valve replacement (SAVR) or BAV (Balloon aortic valvuloplasty) according to VARC-3 criteria

  26. Afib

    Time frame: 30-day, 1-year, 3-year, 5-year and 10-year.

    Newly diagnosed atrial fibrillation according to VARC-3 criteria

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Aalborg University Hospital
  • Odense University Hospital

Registry information

Official study title

Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)

Acronym: Compare-TAVI

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Jun 23, 2020
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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