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New heart procedure aims to zap away atrial fibrillation safely

NCT ID NCT06455098

Disease control Sponsor: Biosense Webster, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study is testing a new device that uses pulsed electric fields to treat paroxysmal atrial fibrillation, a condition where the heart beats irregularly. The procedure aims to isolate the pulmonary veins to restore normal rhythm. Researchers will enroll 440 people who have not responded well to medication and will monitor them for 12 months to check safety and effectiveness.

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 OMNYPULSE catheter and TRUPULSE generator
What this could lead to
If successful, this could offer a safer and more effective way to restore normal heart rhythm in people with paroxysmal atrial fibrillation, reducing symptoms and improving quality of life.
What could go wrong
This is an early-stage study without a control group, so results may not prove superiority over existing treatments. Risks include serious complications like stroke, heart damage, or esophageal 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

353 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Jul 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 to 80 years

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: * Diagnosed with symptomatic paroxysmal AF with: 1. At least two symptomatic AF episodes within last six months from enrollment 2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment * Failed at least one Class I or Class III antiarrhythmic drug * Willing and capable to provide consent * Able and willing to comply with all pre-, post- and follow-up testing and requirements Exclusion Criteria: * Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration) * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. * Previous surgical or catheter ablation for AF * Patients known to require ablation outside the PV ostia and outside the CTI region. * Documented severe dilatation of the left atrium (LAD\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment * Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure * Documented severely compromised left ventricular ejection fraction (LVEF \<40%) by imaging within 6 months prior to enrollment * Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) * Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months * Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months * Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months * Valvular cardiac surgical/percutaneous procedure * Unstable angina within 6 months * Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months * Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * Prior diagnosis of pulmonary vein stenosis * Pre-existing hemi diaphragmatic paralysis * Acute illness, active systemic infection, or sepsis * Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation * Severe mitral regurgitation * Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field) * Presence of a condition that precludes vascular access * Current enrollment in an investigational study evaluating another device or drug * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation * Life expectancy less than 12 months * Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

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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

Contacts and locations

Locations

  • Advent Health Orlando

    Orlando, Florida, 32803, United States

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207, United States

  • Beaumont Health Systems

    Royal Oak, Michigan, 48073, United States

  • Brigham And Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardiovascular Associates of Marin

    Larkspur, California, 94939, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Hoag Memorial Hospital

    Newport Beach, California, 92663, United States

  • Inova Fairfax Medical Campus- Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Massachusetts General

    Boston, Massachusetts, 02114, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Mills Peninsula Health Services

    Burlingame, California, 94010, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55414, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • NCH Healthcare

    Naples, Florida, 34102, United States

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102, United States

  • New York Presbyterian - Weill Cornell Medical Ctr

    New York, New York, 10065, United States

  • NorthShore University Medical Center

    Glenview, Illinois, 60026, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018, United States

  • Piedmont Healthcare

    Atlanta, Georgia, 30309, United States

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • Royal Melbourne Hospital

    Parkville, 03052, Australia

  • San Diego Cardiac Center

    San Diego, California, 92123, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • St Francis Hospital

    Roslyn, New York, 11576, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • Texas Heart Institute

    Houston, Texas, 77030, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • WakeMed Heart & Vascular

    Raleigh, North Carolina, 27610, United States

  • York Hospital

    York, Pennsylvania, 17403, United States

More trials for these conditions

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