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MRI-Guided heart procedure aims to stop dangerous rhythms

NCT ID NCT04694079

Disease control Sponsor: Azienda Ospedaliero, Universitaria Pisana 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether using cardiac MRI to guide ablation (a procedure that destroys small areas of heart tissue) can improve outcomes for people with ventricular tachycardia, a dangerous fast heart rhythm. 104 adults with structural heart disease were randomly assigned to one of three ablation approaches: MRI-guided, MRI-aided, or standard electroanatomical mapping. The goal was to see if MRI guidance reduces the return of abnormal rhythms and makes the procedure safer and more efficient.

What this could mean

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

Active substance
cardiac magnetic resonance (CMR)-guided ablation procedure
What this could lead to
If successful, this approach could make heart ablation more precise and effective, reducing the chance of dangerous heart rhythms returning.
What could go wrong
This is a completed Phase 4 study with 104 participants, but results may not apply to all patients. The benefit of MRI guidance over standard methods is still uncertain.

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

104 people

The number who actually took part.

Started

Aug 2020

Finished

Jul 2025

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: * Indication for VT ablation in patients with SHD (indications according to the 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death); * Structural heart disease (clinical history, EKG, multimodality imaging) * Signed informed consent; Exclusion Criteria: * Age \<18 y; * ICD not already implanted nor expected within 1 month; * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons); * Inability to give written informed consent; * Pregnancy (suspected or confirmed); * Acute coronary syndrome in the previous 3 months; * Creatinine clearance \< 15 ml/min (stage 5 CKD) (according to clinical history or out/in-patient tests performed upon enrollment) * Severe chronic liver disease (Child-Pugh score C) (according to clinical history or out/in-patient tests performed upon enrollment) * Heart surgery for valve disease in the previous 6 months or expected within 6 months, * NYHA functional class IV heart failure or CCS functional class IV angina * Previous VT ablation (redo procedure). * Systemic illness likely to limit survival to \< 1 year

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Conditions

The condition(s) this trial relates to.

endomyocardial fibrosis heart disorder ventricular tachycardia

As listed by the trial registrant

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

Myocardial fibrosis Ventricular tachycardia

Contacts and locations

Locations

  • AOUPisana

    Pisa, PI, 56100, Italy

  • Azienda Ospedaliero Universitaria Senese - U.O.C. Cardiologia, Siena

    Siena, SI, Italy

  • Azienda USL Toscana Nord Ovest - U.O.C. Cardiologia, Ospedale Versilia

    Camaiore, LU, Italy

  • Azienda USL Toscana Nord Ovest- U.O.C. Cardiologia, Ospedali Riuniti - Livorno

    Livorno, LI, 57126, Italy

  • Azienda USL Toscana Sud Est

    Arezzo, AR, Italy

  • Azienda USL Toscana Sud Est- U.O.C. Cardiologia, Ospedale Misericordia - Grosseto

    Grosseto, GR, Italy

  • FTGM

    Pisa, PI, 56100, Italy

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