New heart procedure aims to tame atrial fibrillation without drugs

NCT ID NCT06223789

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

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study tested a new device called the Volt PFA System, which uses pulsed field ablation to treat atrial fibrillation (AF), a common heart rhythm problem. Researchers enrolled 392 people with symptomatic AF that didn't respond to medication. The goal was to see if the procedure is safe and effective at stopping abnormal heart rhythms for at least 12 months.

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 provide a new, safer option for controlling atrial fibrillation without long-term medication.
What could go wrong: This is a completed study, but results are not yet published. Risks include serious complications like heart damage or stroke, and the procedure may not prevent all future arrhythmias.

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

392 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 2025

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 with ≥ 2 episodes of PAF within the 6 months prior to enrollment 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 180 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 PVI catheter ablation procedure 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. Previously diagnosed 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. Patient known to require ablation beyond PVI at the time of consent. 4. Known presence of cardiac thrombus 5. Left atrial diameter ≥ 5.5 cm (anteroposterior diameter) within 180 days of index procedure. 6. Left ventricular ejection fraction \< 35% as assessed with echocardiography within 180 days of index procedure 7. New York Heart Association (NYHA) class III or IV heart failure 8. Body mass index \> 40 kg/m2 9. Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period 10. Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure, 11. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days 12. Unstable angina 13. Stroke or TIA (transient ischemic attack) within the last 90 days 14. Heart disease in which corrective surgery is anticipated within 180 days after procedure 15. History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state 16. Contraindication to long term anti-thromboembolic therapy 17. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation 18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 19. Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device) 20. Presence of any condition that precludes appropriate vascular access 21. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2). 22. Previous tricuspid or mitral valve replacement or repair 23. Patients with prosthetic valves 24. Patients with a myxoma 25. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt 26. Stent, constriction, or stenosis in a pulmonary vein 27. Rheumatic heart disease 28. Hypertrophic cardiomyopathy 29. Diagnosed with amyloidosis or atrial amyloidosis 30. Active systemic infection 31. Renal failure requiring dialysis 32. 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 33. 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. 34. Presence of an implanted LAA closure device or plans to have an LAA closure device implanted during the follow-up period 35. 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 36. Unlikely to survive the protocol follow up period of 12 months 37. 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. 38. Individuals without legal authority 39. 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 atrial fibrillation Persistent atrial fibrillation

Contacts and locations

Locations

A.o. Krankenhaus der Elisabethinen Linz

Linz, 4020, Austria
AZ Sint Jan

Bruges, 8000, Belgium
AdventHealth Orlando

Orlando, Florida, 32803, United States
AdventHealth Tampa

Tampa, Florida, 33613, United States
Affinity Cardiovascular Specialists, LLC

Birmingham, Alabama, 35243, United States
Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States
Az. Osp. Universitaria Osp. Riuniti Umberto I-Lancisi-Salesi

Ancona, 60126, Italy
California Pacific Medical Center - Van Ness Campus

San Francisco, California, 94109, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States
Hopital Pitie Salpetriere

Paris, 75651, France
Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Johns Hopkins University Hospital

Baltimore, Maryland, 21287, United States
Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States
McGill University Health Centre General Hospital

Montreal, Quebec, H4A3J1, Canada
Medical Center of the Rockies

Loveland, Colorado, 80538, United States
Memorial Hermann Hospital

Houston, Texas, 77030, United States
Monash Health

Clayton, 3168, Australia
Motol and Homolka University Hospital

Prague, 15030, Czechia
Northside Hospital

Atlanta, Georgia, 30322, United States
Northwell Health - Lenox Hill Hospital

New York, New York, 10021, United States
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Ohio State University

Columbus, Ohio, 43210, United States
Royal Adelaide Hospital

Adelaide, 5000, Australia
Royal Melbourne Hospital

Parkville, 3050, Australia
Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States
Southcoast Hospitals Group - Charlton Memorial Hospital

Fall River, Massachusetts, 02720, United States
St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom
Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States
The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
The Prince Charles Hospital

Chermside, 4032, Australia
Trident Medical Center

Charleston, South Carolina, 29406, United States
UMC Utrecht

Utrecht, 3584 CX, Netherlands
UZ Brussel

Brussels, 1090, Belgium
Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

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