A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator (Omny-IRE)

Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • AZORG campus Aalst Moorselbaan
  • Bruges, Belgium, 8000
    • AZ Sint-Jan
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
• Croatia
  • Split, Croatia, 21000
    • KBC Split
• Czechia
  • Prague, Czechia, 150 30 District 5
    • Nemocnice Na Homolce
  • Prague, Czechia, 140 21
    • IKEM
• Germany
  • Frankfurt a.M., Germany, 60431
    • MVZ CCB Frankfurt und Main Taunus GbR
• Italy
  • Acquaviva delle Fonti, Italy, 70021
    • Generale Regionale F. Miulli
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santariskiu Klinikos
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF) defined as as atrial fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
• Selected for AF ablation procedure by pulmonary vein isolation (PVI)
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

• Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [body mass index greater than {>} 40 kilograms per meter square {kg/m^2}]), renal insufficiency (with an estimated creatinine clearance less than (<) 30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2])
• Previous left atrium (LA) ablation or surgery
• Participants known to require ablation outside the PV region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
• Previously diagnosed with persistent AF (> 7 days in duration)
• Severe dilatation of the left atrium (LA) (left anterior descending artery [LAD] >50 millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
• Presence of LA thrombus
• Severely compromised left ventricular ejection fraction (left ventricular ejection fraction [LVEF] <40 percentage [%])
• 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)
• History of a documented thromboembolic event (including transient ischemic attack [TIA]) within the past 6 months
• Previous percutaneous coronary intervention (PCI) / myocardial infarction (MI) within the past 2 months
• Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
• Unstable angina pectoris within the past 6 months
• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
• Significant pulmonary disease (example, 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
• Known significant pulmonary vein (PV) anomaly 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 implanted pacemaker or implantable cardioverter-defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
• Presence of a condition that precludes vascular access (such as Inferior Vena Cava [IVC] filter)
• Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study
• Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
• 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)
• Known contraindication for magnetic resonance imaging (MRI) such as use of contrast agents due to advanced renal disease, claustrophobia etcetra. (at principle investigator [PI] discretion)
• Presence of iron-containing metal fragments in the body
• Known unresolved pre-existing neurological deficit
• Known uncontrolled significant gastroesophageal reflux disease (GERD)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator; Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).

Device: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator; Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping [stimulating and recording] and, when used with a Generator, for cardiac ablation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Primary Adverse Events (PAEs)	Percentage of participants with PAEs was reported. PAEs (within seven [7] days of the index ablation procedure) included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (up to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation (up to 30 days post-procedure), stroke/cerebrovascular accident (CVA), major vascular access complication, major bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.	90 days post catheter insertion on Day 0
Percentage of Participants With Acute Effectiveness Success	Percentage of participants with acute effectiveness success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PV; confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.	Immediately post-procedure on Day 0 (post catheter insertion)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia Episodes and Acute Procedural Failure	From Day 91 to Day 365 post catheter insertion on Day 0

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Director: Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial, Biosense Webster, Inc., a division of Johnson & Johnson

Publications and helpful links

General Publications

• Duytschaever M, Grimaldi M, De Potter T, Verma A, Macle L, Kautzner J, Linz D, Anic A, Van Herendael H, Rackauskas G, Neuzil P, Chun J, Schmidt B, Knecht S, Almorad A, Berte B, Reddy VY, Vijgen J. PVI With CF-Sensing Large-Tip Focal PFA Catheter With 3D Mapping for Paroxysmal AF: Omny-IRE 3-Month Results. JACC Clin Electrophysiol. 2025 Aug;11(8):1769-1782. doi: 10.1016/j.jacep.2025.04.008. Epub 2025 Apr 25.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: BWI202201 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes