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Can a new heart ablation technique work without x-rays?

NCT ID NCT07752771

Disease control Sponsor: Semmelweis University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether a newer type of heart ablation, called pulsed-field ablation, can effectively isolate the pulmonary veins in people with paroxysmal atrial fibrillation while using very little or no X-ray guidance. The procedure uses the Farapulse system with a special mapping module and ultrasound-guided access. Researchers will check how durable the isolation is by performing a repeat heart mapping procedure three months later, along with MRI and CT scans to see the scar tissue. The goal is to see if this safer, radiation-sparing approach can be a reliable treatment option.

What this could mean

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

Active substance
Pulsed-field ablation using the Farapulse system (Farawave catheter, Faradrive sheath, Faraview module) to isolate pulmonary veins
What this could lead to
If successful, this could show that a safer, radiation-sparing approach to heart ablation is both feasible and effective for treating atrial fibrillation.
What could go wrong
This is a small, single-center study with only 20 participants, so results may not apply broadly. The procedure carries risks like bleeding, heart damage, or arrhythmia recurrence.

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

Apr 2025

Finished

Dec 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: * Symptomatic paroxysmal AF * Age \>18 years * Willingness to sign the informed consent form Exclusion Criteria: * Contraindication to ablation * Contraindication of long-term anticoagulation * Persistent AF * History of typical or atypical flutter * History of PVI * History of cardiac surgery * Contraindication of cardiac MRi examination * Pregnancy * Active malignancy * Life expectancy \<1 year * Valvular AF * Reversible cause of AF (e.g. hyperthyroidism).

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF) Pulsed field ablation

Contacts and locations

Locations

  • Semmelweis University

    Budapest, Pest County, 1122, Hungary

More trials for these conditions

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