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Heart valve showdown: intermediate sizing may reduce complications in aortic stenosis

NCT ID NCT07689279

Disease control Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests whether a newer balloon-expandable heart valve with intermediate sizes (Myval) is as safe as a standard self-expanding valve (Evolut) in people with severe aortic stenosis whose valve measurements fall in a 'borderline' range. About 600 participants will be randomly assigned to receive one of the two valves during a routine transcatheter aortic valve replacement (TAVI). The study will track safety events like death, stroke, bleeding, and need for a pacemaker within 30 days, and follow patients for up to 5 years to see how well the valve works over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcatheter heart valve (Myval or Evolut series)
What this could lead to
If the Myval valve with intermediate sizes proves safer or equally safe, it could offer a better fit for people with borderline anatomy, reducing complications.
What could go wrong
This is a phase 4 trial comparing existing devices, not a new cure. The benefit may be small, and complications like bleeding or need for a pacemaker are still possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 604 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

A potential participant is deemed eligible for trial participation if the following criteria are met: 1. TAVI as decided by local multidisciplinary heart team 2. CT-derived annular perimeters fall within the following ranges: * 55.5 - 57.5 mm * 61.0 - 64.5 mm * 70.5 - 74.0 mm * 79.5 - 84.0 mm * 92.0 - 96.0 mm 3. Written informed consent Exclusion Criteria: A potential participant will be excluded from trial participation in case of inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis, severe

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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