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Atrial FibrillationOMNY-AFNCT06455098

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

A study testing OMNYPULSE™ Catheter with the TRUPULSE Generator in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 41 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
OMNYPULSE™ Catheter with the TRUPULSE Generator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
41 sitesin 2 countries
Study dates
28 Jun 2024to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with symptomatic paroxysmal AF with:
  • At least two symptomatic AF episodes within last six months from enrollment
  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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)

Trial locations and contacts

41 sites in 2 countries.

41 sites in 2 countries

United States39 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Colorado

    Aurora, Colorado, 80045

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Massachusetts General

    Boston, Massachusetts, 02114

  • Brigham And Women's Hospital

    Boston, Massachusetts, 02115

  • Mills Peninsula Health Services

    Burlingame, California, 94010

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Inova Fairfax Medical Campus- Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

  • NorthShore University Medical Center

    Glenview, Illinois, 60026

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Texas Heart Institute

    Houston, Texas, 77030

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207

  • Cardiovascular Associates of Marin

    Larkspur, California, 94939

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55414

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Intermountain Medical Center

    Murray, Utah, 84107

  • NCH Healthcare

    Naples, Florida, 34102

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • New York Presbyterian - Weill Cornell Medical Ctr

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Advent Health Orlando

    Orlando, Florida, 32803

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • WakeMed Heart & Vascular

    Raleigh, North Carolina, 27610

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • St Francis Hospital

    Roslyn, New York, 11576

  • Beaumont Health Systems

    Royal Oak, Michigan, 48073

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Royal Melbourne Hospital

    Parkville, 03052

Other trials in Australia

About this study

Official title: Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter

The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Being tested
OMNYPULSE™ Catheter with the TRUPULSE Generator
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMNYPULSE™ Catheter with the TRUPULSE GeneratorDevice

    OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.

Study groups in NCT06455098
Study groupRoleWhat they receive
Pulsed Field (PF) Ablation SystemExperimentalParticipants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.
Receives: Device: OMNYPULSE™ Catheter with the TRUPULSE Generator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Primary Adverse Events (PAEs)

    Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.

    Measured: 7 days post-procedure

  2. Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes

    Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of >= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported.

    Measured: Day 91 to Day 365 post-procedure

Secondary outcomes (1)

  1. Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score

    The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.

    Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start28 Jun 2024
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455098
Sponsor's protocol ID
BWI202303
Other IDs
BWI202303
Acronym
OMNY-AF
Status last verified
Sep 2026
First submitted
7 Jun 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A study testing OMNYPULSE™ Catheter with the TRUPULSE Generator in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 41 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Primary Adverse Events (PAEs) (time frame: 7 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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