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Heart valve positioning study aims to prevent artery blockage

NCT ID NCT07217691

Knowledge-focused Sponsor: Oslo University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two established techniques for placing a TAVI heart valve to see which one better aligns the valve with the patient's own valve openings, reducing the risk of blocking coronary arteries. Forty patients with severe aortic stenosis will be randomly assigned to one of the two methods. After the procedure, a CT scan checks the valve's position. The goal is to identify a technique that could become the new standard, improving safety and outcomes.

What this could mean

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

Active substance
Evolut FX+ transcatheter aortic valve implantation device
What this could lead to
If one technique proves better, it could become the new standard for TAVI procedures, improving patient safety and reducing coronary blockage risks.
What could go wrong
This is a small, early-stage study (40 participants) comparing two already-used techniques. It may not show a clear difference, and results may not apply to all patients or valve types.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

May 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Inclusion Criteria: * Patients with severe aortic stenosis indicated for TAVI after heart team meeting. * Age ≥65 years. * Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve). * Patients providing informed consent. Exclusion Criteria: * Severe peripheral vascular disease preventing transfemoral access. * Prior aortic valve replacement or bicuspid valve. * Severely reduced kidney function (estimated glomerular filtration rate \<30).

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis commissural facial cleft

As listed by the trial registrant

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

Aortic stenosis Commissural alignment Trans-catheter aortic valve implantation

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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