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New combo ablation aims to stop AFib in its tracks

NCT ID NCT07171463

Disease control Sponsor: St. Joseph's Centre, Poland 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new approach for treating paroxysmal atrial fibrillation (a type of irregular heartbeat). It combines two procedures: pulsed-field ablation to isolate the pulmonary veins, plus targeted thermal ablation of a nerve cluster near the heart. The goal is to see if adding the thermal step reduces AFib recurrence and dangerous slow heart rates during the procedure. Twenty adults with documented paroxysmal AFib will be randomly assigned to receive either the standard ablation or the combo treatment.

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 and radiofrequency ablation
What this could lead to
If successful, this combination approach could reduce AFib recurrence and the need for repeat procedures.
What could go wrong
This is a very small early-stage trial with only 20 participants, so results may not apply broadly. The added thermal ablation also carries risks like nerve damage or heart tissue injury.

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 20 people

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

Started

May 2025

Expected to finish

Sep 2026

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: * Age ≥18 years * Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring * Willingness and ability to provide written informed consent * Life expectancy \>1 year Exclusion Criteria: * Persistent AF lasting \>7 days or long-standing AF \>1 year * Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes * Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography * Clinically significant coexisting arrhythmias other than AF * Significant valvular heart disease or valve prosthesis * Chronic heart failure NYHA class III/IV * Previous AF or atrial flutter ablation * Prior closure of atrial septal defect or left atrial appendage * Atrial myxoma * Implanted pacemaker or defibrillator * History of pericarditis * Congenital heart disease * Coagulopathy or bleeding disorders * Contraindications to oral anticoagulation * Contraindications to CT or MRI * Pregnancy or breastfeeding * Body Mass Index \>30 * History of organ transplantation * Severe pulmonary disease * Estimated Glomerular Filtration Rate \<30 mL/min/1.73 m² * Active malignancy * Significant infection * Life expectancy \<1 year * Psychiatric disorders preventing study participation * Refusal or inability to provide informed consent

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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 (paroxysmal)

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

  • St. Joseph's Heart Rhythm Center

    RECRUITING

    Rzeszów, Podkarpackie Voivodeship, 35-623, Poland

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