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Heart ablation showdown: which technique stops fainting best?

NCT ID NCT07162740

Disease control Sponsor: Istituto Auxologico Italiano 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests two heart ablation methods—right atrial only vs. bi-atrial—to see which better prevents fainting caused by reflex syncope. Fifty adults aged 18–60 with severe, recurrent fainting will be monitored with an implantable loop recorder. The goal is to find the most effective and safe technique to reduce asystolic episodes.

What this could mean

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

Active substance
cardioneuroablation (a procedure that uses heat to disable nerve clusters in the heart)
What this could lead to
If successful, this study could identify the best ablation technique to reduce or prevent fainting spells in people with reflex syncope.
What could go wrong
This is a small, early-stage study (50 people) comparing two existing procedures, so results may not apply broadly. Ablation carries risks like bleeding, infection, or heart rhythm issues.

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.

Participants

About 50 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 2027

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.

Who is studied

Established asystolic reflex syncope

Ages

18 to 18 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: * Age 18 to 60 years * Clinical diagnosis of reflex syncope as per class I criteria of the ESC guidelines * History of recurrent severe syncopes (≥2 in the last year or ≥3 in the last 2 years), significantly affecting the quality of life, nonresponding to lifestyle measures. * Documentation by means of prolonged ECG monitoring of an asystolic pause \>6 sec or of an asystolic syncope \>3 sec and/or an asystolic syncope induced during tilt testing (Vasis 2B form). Exclusion Criteria: * Intrinsic sinus dysfunction or atrioventricular node disease. * Constitutional hypotension and orthostatic intolerance syndromes * Overt structural heart disease * Alternative diagnoses of syncope * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

cardiac arrest Syncope syncope, familial vasovagal Syncope, Vasovagal

As listed by the trial registrant

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

Reflex syncope

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • IRCCS Istituto Auxologico Italiano

    Milan, 20149, Italy

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