Comparison of Eligible TAVI-valves - Cohort B (Compare-TAVI)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2032
  • participants needed
    1062
  • sponsor
    Aarhus University Hospital Skejby
Updated on 9 August 2022

Summary

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

Description

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
  1. 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.
  2. 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.

Details
Condition Transcatheter Aortic Valve Implantation
Treatment chosen TAVI valve
Clinical Study IdentifierNCT04443023
SponsorAarhus University Hospital Skejby
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

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
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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