New heart procedure aims to zap away atrial fibrillation safely

NCT ID NCT06455098

Recruiting now Disease control Sponsor: Biosense Webster, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

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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
RECRUITING

Orlando, Florida, 32803, United States
Ascension St. Vincent's
RECRUITING

Jacksonville, Florida, 32204, United States
Baptist Health Research Institute
RECRUITING

Jacksonville, Florida, 32207, United States
Beaumont Health Systems
RECRUITING

Royal Oak, Michigan, 48073, United States
Brigham And Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
California Pacific Medical Center- Sutter Health
WITHDRAWN

San Francisco, California, 94109, United States
Canberra Heart Rhythm
WITHDRAWN

Garran, 2605, Australia
Cardiovascular Associates of Marin
RECRUITING

Larkspur, California, 94939, United States
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Emory Saint Joseph's Hospital
RECRUITING

Atlanta, Georgia, 30342, United States
HCA Florida Mercy Hospital
RECRUITING

Miami, Florida, 33133, United States
Hartford Hospital
RECRUITING

Hartford, Connecticut, 06102, United States
Hoag Memorial Hospital
RECRUITING

Newport Beach, California, 92663, United States
Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
RECRUITING

Falls Church, Virginia, 22042, United States
Intermountain Medical Center
RECRUITING

Murray, Utah, 84107, United States
Johns Hopkins
RECRUITING

Baltimore, Maryland, 21287, United States
Lenox Hill Hospital
RECRUITING

New York, New York, 10075, United States
Loma Linda Medical Center
WITHDRAWN

Loma Linda, California, 92354, United States
Massachusetts General
RECRUITING

Boston, Massachusetts, 02114, United States
Memorial Health University Medical Center
RECRUITING

Savannah, Georgia, 31404, United States
Mills Peninsula Health Services
RECRUITING

Burlingame, California, 94010, United States
Minneapolis Heart Institute
RECRUITING

Minneapolis, Minnesota, 55414, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
Morristown Medical Center
RECRUITING

Morristown, New Jersey, 07960, United States
Mount Sinai School of Medicine
RECRUITING

New York, New York, 10029, United States
NCH Healthcare
RECRUITING

Naples, Florida, 34102, United States
New Mexico Heart Institute
RECRUITING

Albuquerque, New Mexico, 87102, United States
New York Presbyterian - Weill Cornell Medical Ctr
RECRUITING

New York, New York, 10065, United States
NorthShore University Medical Center
RECRUITING

Glenview, Illinois, 60026, United States
Northside Hospital
RECRUITING

Atlanta, Georgia, 30342, United States
Phoenix Cardiovascular Research Group
RECRUITING

Phoenix, Arizona, 85018, United States
Piedmont Healthcare
RECRUITING

Atlanta, Georgia, 30309, United States
Providence Saint John s Health Center
WITHDRAWN

Santa Monica, California, 90404, United States
Royal Adelaide Hospital
RECRUITING

Adelaide, 5000, Australia
Royal Melbourne Hospital
RECRUITING

Parkville, 03052, Australia
San Diego Cardiac Center
RECRUITING

San Diego, California, 92123, United States
Scripps Clinic/Prebys Cardiovascular Institute
WITHDRAWN

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital
RECRUITING

Norfolk, Virginia, 23507, United States
St Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
Texas Cardiac Arrhythmia Research Foundation
RECRUITING

Austin, Texas, 78705, United States
Texas Heart Institute
RECRUITING

Houston, Texas, 77030, United States
University of Colorado
RECRUITING

Aurora, Colorado, 80045, United States
University of Pennsylvania Health System
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Virginia Commonwealth University
RECRUITING

Richmond, Virginia, 23298, United States
WakeMed Heart & Vascular
RECRUITING

Raleigh, North Carolina, 27610, United States
York Hospital
RECRUITING

York, Pennsylvania, 17403, United States

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