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Heart burn: can zapping heart tissue stop deadly rhythms in brugada syndrome?

NCT ID NCT05685134

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a procedure called radiofrequency catheter ablation in 20 people with Brugada syndrome, a heart condition that can cause dangerous heart rhythms. Half received the real ablation, which uses heat to destroy small areas of heart tissue thought to cause the problem, while the other half received a sham procedure. The goal was to see if the ablation could normalize the heart's electrical pattern and prevent life-threatening arrhythmias over one year.

What this could mean

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

Active substance
radiofrequency catheter ablation
What this could lead to
If successful, this procedure could reduce the risk of dangerous heart rhythms and potentially decrease the need for an implantable defibrillator in Brugada syndrome patients.
What could go wrong
This is a very small, early-stage trial with only 20 participants. The procedure involves burning heart tissue and carries risks like bleeding, infection, or heart damage. Results may not apply to all 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

20 people

The number who actually took part.

Started

Nov 2020

Finished

Apr 2026

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 to 70 years

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 a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams * Patients clinically stable for at least six months before the enrollment * Able to cope with follow-up visits up to one year after the intervention * Patients who have signed the written informed consent Exclusion Criteria: * Pregnant women * Patients with structural heart disease * Patients with a known cardiac or systemic autonomic disorder * Patients with a history of previous right ventricular outflow tract ablation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Instituto do Coração - InCor - HC/FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

More trials for these conditions

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