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A Needle-Free heart check? MRI may replace invasive catheterization

NCT ID NCT07742046

Diagnosis Sponsor: Tobias Rutz 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study tests whether a new MRI technique, called 5D flow, can measure blood flow and pressure in the heart as accurately as the standard invasive procedure, right-left heart catheterization. People with congenital heart conditions who already need a catheterization will also have an MRI on the same day. The researchers will compare the MRI results to the catheterization results to see if the MRI could be a reliable, non-invasive alternative.

What this could mean

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

Active substance
5D flow cardiac magnetic resonance imaging (MRI) as a non-invasive diagnostic test
What this could lead to
If successful, this could reduce the need for invasive heart catheterization in some patients with congenital heart disease, making diagnosis safer and more comfortable.
What could go wrong
The MRI technique is still being tested and may not match the accuracy of the gold-standard catheterization. It may only work for certain conditions or patients.

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 130 people

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

Started

Jul 2026

Expected to finish

May 2029

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

16 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.

Inclusion Criteria: * Referral for work-up of known or suspected pulmonary hypertension (PH), RVOT pathology, or Fontan-type repair with a clinical indication for RL-HC. * Ability to provide informed consent or have consent provided by a legal representative (and assent for minors aged 16-18). * Male or female participants of all ethnicities and sociodemographic backgrounds Exclusion Criteria: * Participants unable to comply with study procedures due to language barriers, cognitive or psychological limitations, or lack of legal consent. * Patients with contraindications to RL-HC or CMR. * Patients not having a clinical indication to RL-HC.

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Conditions

The condition(s) this trial relates to.

congenital heart disease pulmonary hypertension

As listed by the trial registrant

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

Fontan circulation Pulmonary hypertension Right ventricular outflow tract dysfunction

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Lausanne University Hospital

    Lausanne, 1011, Switzerland

More trials for these conditions

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