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New heart ablation device shows promise for common irregular heartbeat

NCT ID NCT06271967

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new system that uses electrical pulses to treat a type of irregular heartbeat called paroxysmal atrial fibrillation (AF). The system includes a special catheter and generator designed to safely and effectively stop the faulty signals causing the condition. 150 adults with symptomatic AF participated to see if the treatment could prevent episodes for at least 6 months.

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

150 people

The number who actually took part.

Started

Aug 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Documented symptomatic paroxysmal AF (PAF). Documentation requirements are as follows: 1. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND 2. One electrocardiographically documented PAF episode within 12 months prior to enrollment. 2. Plans to undergo a catheter ablation procedure due to symptomatic PAF 3. At least 18 years of age 4. Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements 5. Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site. Exclusion Criteria: 1. Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration) 2. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days 3. Known presence of cardiac thrombus 4. Left atrial diameter (LAD) ≥ 5.5 cm (anteroposterior diameter) within 180 days prior to the index procedure 5. Left ventricular ejection fraction (LVEF) \< 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure 6. New York Heart Association (NYHA) class III or IV heart failure 7. Body mass index \> 40 kg/m2 8. Pregnant or nursing 9. Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure 10. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days 11. Stroke or TIA (transient ischemic attack) within the last 90 days 12. Heart disease in which corrective surgery is anticipated within 180 days after procedure 13. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state 14. Contraindication to long term anti-thromboembolic therapy 15. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 16. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 17. Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device) 18. Plans to have an LAA closure device implanted during the follow-up period 19. Presence of any condition that precludes appropriate vascular access 20. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2). 21. Previous tricuspid or mitral valve replacement or repair 22. Patients with prosthetic valves 23. Patients with a myxoma 24. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 25. Stent, constriction, or stenosis in a pulmonary vein 26. Rheumatic heart disease 27. Hypertrophic cardiomyopathy 28. Active systemic infection 29. Renal failure requiring dialysis 30. Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms 31. Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device. 32. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor 33. Unlikely to survive the protocol follow up period of 12 months 34. Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 35. Individuals without legal authority 36. Individuals unable to read or write

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac 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

  • A. ö. Krankenhaus der Elisabethinen Linz

    Linz, UPR AUS, 4020, Austria

  • CHU Trousseau

    Chambray-lès-Tours, Centre-Val de Loire, 37170, France

  • Centro Cardiologico Monzino

    Milan, Lombard, 20138, Italy

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, Bavaria, 80636, Germany

  • Haga Ziekenhuis Locatie Leyenburg

    The Hague, ZUID, 2545AA, Netherlands

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, N. RHIN, 32545, Germany

  • Hopital Haut Leveque

    Pessac, Aquitaine, 33604, France

  • Hospital Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, Valncia, 46026, Spain

  • Hôpital Pitié Salpetrière

    Paris, ILE, 75651, France

  • Leiden University Medical Center

    Leiden, Zuid, 2333 ZA, Netherlands

  • Nemocnice Ceske Budejovice, a.s.

    České Budějovice, Sbohmia, 37001, Czechia

  • Ospedale San Raffaele

    Milan, Lombard, 20132, Italy

  • Peninsula Private Hospital

    Langwarrin, Victoria, 3910, Australia

  • Royal Adelaide Hospital

    Adelaide, Saustrl, 5000, Australia

  • Royal Melbourne Hospital - City Campus

    Parkville, Victoria, 3050, Australia

  • Skejby University Hospital

    Aarhus, Arhus, 8200, Denmark

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • The Royal Sussex County Hospital

    Brighton, Soeast, BN25BE, United Kingdom

  • UZ Brussel

    Brussels, B CAP R, 1090, Belgium

  • Universitair Medische Centrum Groningen

    Groningen, Grogen, 9713 GZ, Netherlands

  • Universitätsklinik Graz

    Graz, Styria, 8036, Austria

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

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