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New Balloon-Based ablation device tested in Real-World AFib patients

NCT ID NCT07181590

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study is tracking 300 people with paroxysmal or persistent atrial fibrillation (AFib) who are treated with the Volt PFA System, a balloon-based device that uses pulsed field ablation to correct irregular heart rhythms. Researchers are monitoring safety—looking for serious side effects within 7 days—and effectiveness, such as freedom from AFib recurrence over 12 months. The goal is to see how well the device works in real-world settings, not just in controlled trials.

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 Volt PFA System
What this could lead to
If successful, this could confirm that the Volt PFA System is a safe and effective option for treating atrial fibrillation in everyday medical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Risks include serious complications like heart damage or stroke, though the study aims to measure how often these occur.

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 300 people

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

Started

Dec 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

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 PAF or PersAF. Documentation requirements are as follows: Paroxysmal: * Physician's note indicating recurrent self-terminating AF AND * One electrocardiographically documented PAF episode within 12 months prior to enrollment. Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by * Physician's note, AND either * 24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR * Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF: * That are taken at least 7 days apart but less than 12 months apart * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment * The most recent electrocardiogram must be within 180 days of enrollment. NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device. 2. Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication 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. 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 2. Known presence of cardiac thrombus 3. Known Left ventricular ejection fraction \< 35% as assessed with echocardiography within 360 days of index procedure 4. New York Heart Association (NYHA) class III or IV heart failure 5. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period 6. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure 7. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days 8. Unstable angina 9. Stroke or TIA (transient ischemic attack) within the last 90 days 10. Heart disease in which corrective surgery is anticipated within 180 days after procedure 11. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state 12. Contraindication to long term anti-thromboembolic therapy 13. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 14. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device) 15. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2). 16. Previous tricuspid or mitral valve replacement or repair 17. Patients with prosthetic valves 18. Patients with a myxoma 19. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 20. Stent, constriction, or stenosis in a pulmonary vein 21. Rheumatic heart disease 22. Hypertrophic cardiomyopathy 23. Diagnosed with amyloidosis or atrial amyloidosis 24. Active systemic infection 25. Renal failure requiring dialysis 26. 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 27. Presence of an implanted LAA closure device 28. Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm 29. Unlikely to survive the protocol follow up period of 12 months 30. 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. 31. Individuals without legal authority 32. Individuals unable to read or write

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial arrhythmia Atrial fibrillation Paroxysmal af Persistent atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 12 countries. 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

  • AZ Sint Jan

    RECRUITING

    Bruges, 8000, Belgium

  • Asklepios Klinik St. Georg

    RECRUITING

    Hamburg, 20099, Germany

  • Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi

    RECRUITING

    Ancona, 60126, Italy

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, 20138, Italy

  • Clinique Pasteur Toulouse

    RECRUITING

    Toulouse, 31076, France

  • Herz-und Diabetes Zentrum NRW

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • Hopital Haut Leveque

    RECRUITING

    Pessac, 33600, France

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Hospital Universitario Doce de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hôpital Pitié Salpetrière

    RECRUITING

    Paris, 75013, France

  • Karolinska University Hospital Huddinge

    RECRUITING

    Stockholm, 14186, Sweden

  • Mater Private Hospital

    RECRUITING

    Dublin, DUBLIN 7, Ireland

  • Medizinische Einrichtungen der Universität zu Köln

    RECRUITING

    Cologne, 50937, Germany

  • National Institute of Cardiology Warsaw

    RECRUITING

    Warsaw, 04-628, Poland

  • Ordensklinikum Linz Elisabethinen

    RECRUITING

    Linz, 4020, Austria

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • St. Antonius Ziekenhuis

    RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • TUM Klinikum - Deutsches Herzzentrum München

    RECRUITING

    München, 80636, Germany

  • ULS de Lisboa Ocidental

    RECRUITING

    Lisbon, 2799-523, Portugal

  • UZ Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • Universitair Medisch Centrum Groningen

    NOT_YET_RECRUITING

    Groningen, 9713 GZ, Netherlands

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