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

NCT ID: NCT05971693

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2025-09-05

Brief Summary

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial

Role: STUDY_DIRECTOR

Biosense Webster, Inc., a division of Johnson & Johnson

Locations

AZORG campus Aalst Moorselbaan

Aalst, , Belgium

AZ Sint-Jan

Bruges, , Belgium

Ziekenhuis Oost-Limburg

Genk, , Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, , Belgium

Montreal Heart Institute

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

KBC Split

Split, , Croatia

IKEM

Prague, , Czechia

Nemocnice na Homolce

Prague, , Czechia

MVZ CCB Frankfurt und Main Taunus GbR

Frankfurt a.M., , Germany

Generale Regionale F. Miulli

Acquaviva delle Fonti, , Italy

Vilnius University Hospital Santariskiu Klinikos

Vilnius, , Lithuania

Maastricht UMC

Maastricht, , Netherlands

Countries

Belgium; Canada; Croatia; Czechia; Germany; Italy; Lithuania; Netherlands

References

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.

Reference Type: DERIVED

PMID: 40340298 (View on PubMed)

Other Identifiers

BWI202201

Identifier Type: OTHER

Identifier Source: secondary_id

BWI202201

Identifier Type: -

Identifier Source: org_study_id