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New ablation tools battle for better heart rhythm control

NCT ID NCT07175727

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested two non-thermal ablation systems in 100 people with paroxysmal atrial fibrillation to see which works better and is safer. Patients were randomly assigned to one of the two devices, and their heart rhythms were monitored for a year. The goal was to find out which system reduces irregular heartbeats more effectively with fewer side effects.

What this could mean

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

Active substance
non-thermal ablation device (pulmonary vein isolation)
What this could lead to
If one system proves safer or more effective, it could become the preferred option for controlling atrial fibrillation with fewer complications.
What could go wrong
This is a small, completed study comparing already-approved devices, so results may not apply to all patients or guarantee long-term success.

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

100 people

The number who actually took part.

Started

Jan 2023

Finished

May 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: * Recurrent, symptomatic paroxysmal atrial fibrillation * Age \> 18 years * Patient consen Exclusion Criteria: * Refusal of the patient * Inability to provide informed consent * Life expectancy \< 2 years * Pregnancy and breastfeeding (due to radiation exposure) * History of left atrial ablation * Known macro-reentry or focal atrial tachycardia * Significant mitral valve stenosis * History of heart valve replacement or reconstruction * NYHA class III and IV * Left ventricular ejection fraction \< 35% * Left atrial enlargement \> 55 mm on echocardiography * Intracardiac thrombus prior to the procedure * Severe pulmonary disease with abnormal blood gases or requiring oxygen therapy * Renal insufficiency (GFR \< 30 mL/min) due to contrast medium use * Stroke or TIA within the last 6 months * Symptomatic carotid stenosis * Active malignancy within the previous 24 months * Untreated or uncontrolled thyroid disease * Active bleeding or chronic bleeding tendency not amenable to curative treatment * Body mass index \> 35 kg/m² * Contraindication to CT examination (e.g., contrast medium allergy or severe claustrophobia)

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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)

Contacts and locations

Locations

  • Alfried Krupp Hospital

    Essen, North Rhine-Westphalia, 45131, Germany

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