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Heart rhythm showdown: second ablation or drugs after first success?

NCT ID NCT06669299

Disease control Sponsor: IRCCS Ospedale San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 people with an implanted defibrillator who had a successful first procedure to fix a dangerous fast heart rhythm (ventricular tachycardia). A few days later, they get a non-invasive heart stimulation test. If the test triggers the rhythm again, patients are randomly assigned to either a second ablation or medication. The goal is to see which approach better prevents the rhythm from coming back.

What this could mean

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

Active substance
catheter ablation procedure
What this could lead to
If successful, this could establish a better strategy to prevent life-threatening heart rhythm recurrences after a first ablation, reducing the need for medication.
What could go wrong
This is a small, early-phase study with only 51 participants, so results may not apply broadly. The procedure carries risks like bleeding, infection, or heart damage.

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 51 people

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

Started

Jun 2025

Expected to finish

Dec 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.

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: * Patients with an implanted ICD (all brands) * Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM. * Induction of monomorphic VT at NIPS 3-7days after a successful index procedure * Age 18 years or more * Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol. Exclusion Criteria: * Inducible VT after index procedure * Contraindication to anticoagulants * Presence of thrombi * Presence of Mitral and Aortic prosthetic valve * Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass * Pregnant or nursing * Ventricular Tachycardia caused by reversible pathology * \< 1 Year life expectancy according to the investigator

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Conditions

The condition(s) this trial relates to.

ventricular tachycardia

As listed by the trial registrant

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

Ventricular tachycardia (VT)

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

  • San Raffaele Hospital, Arrhythmology and Electrophysiology unit

    RECRUITING

    Milan, Italy, 20132, Italy

More trials for these conditions

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