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Heart MRI may outshine ultrasound for valve surgery timing

NCT ID NCT07366723

Knowledge-focused Sponsor: Centro Cardiologico Monzino 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether using a cardiac MRI (CMR) instead of the usual ultrasound helps doctors make better decisions about heart valve surgery for people with severe mitral regurgitation (a leaky heart valve). About 260 adults with no symptoms but severe leakage will be followed for two years. The goal is to see if MRI-guided decisions lead to healthier heart chamber sizes and fewer complications.

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

260 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Dec 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

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.

Inclusion Criteria: * age ≥ 18 years; * patients agree to all provisions of the protocol; * patient can give informed consent; * TTE diagnosis of MVP (defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the MV annulus in long-axis views), and chronic severe MR; * no symptoms; * LVEF \> 60%, LVESD \< 40 mm and LVESDi \< 20 mm/m2; * sinus rhythm; * PASP value at rest \< 50 mmHg; * LA volume index ≥ 60 mL/m2 or diameter ≥ 55 mm or normal LA size if likelihood of a successful and durable repair without residual MR is \>95% and expected mortality rate is \<1% * ongoing adequate treatment per applicable standards; * patient referred for isolated MV repair or replacement; * willingness to undergo TTE, CMR and CPET at different timepoints Exclusion Criteria: * inability to provide informed consent; * pregnancy or planned pregnancy within next 2 years; * poor TTE image quality; * usual contraindications to CMR and/or to gadolinium administration; * inability to sustain a breath hold; * known intracardiac shunts; * coexistence of other cardiomyopathies or other \> mild valve diseases; * untreated clinically significant coronary artery disease requiring revascularization; * planned concomitant cardiac surgical procedures (e.g. other valve procedures, or coronary artery bypass); * need for an emergent/urgent surgery for any reason or any planned cardiac surgery within the next months; * hemodynamic instability requiring inotropic support or mechanical heart assistance; * sustained cardiac arrhythmias; * active endocarditis; * like expectancy \< 12 months due to non-cardiac conditions.

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency mitral valve prolapse

As listed by the trial registrant

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

Mitral regurgitation Mitral valve prolapse

Contacts and locations

Locations

  • Centro Cardiologico Monzino, IRCCS

    Milan, Milan, 20131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.