Atrial FibrillationOmny-IRENCT05971693
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
A study testing OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 13 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 12 Sep 2023to 5 Sep 2025
- Phase
- Interventional
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
Belgium4 sites
AZORG campus Aalst Moorselbaan
Aalst, 9300
AZ Sint-Jan
Bruges, 8000
Ziekenhuis Oost-Limburg
Genk, 3600
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Czechia2 sites
IKEM
Prague, 140 21
Nemocnice na Homolce
Prague, 150 30 District 5
Lithuania1 site
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661
About this study
Official title: 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).
- Conditions
- Atrial Fibrillation
- Being tested
- OMNYPULSE Bi-Directional Catheter with 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 Bi-Directional Catheter with TRUPULSE GeneratorDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator | Experimental | 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). Receives: Device: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately post-procedure on Day 0 (post catheter insertion)
Secondary outcomes (1)
Percentage of Participants With Freedom From Combined Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia Episodes and Acute Procedural Failure
Percentage of participants with freedom from combined documented (symptomatic and asymptomatic) atrial arrhythmia episodes and acute procedural failure were reported. Effectiveness success was defined as freedom from documented (symptomatic and asymptomatic) atrial arrhythmia (atrial fibrillation, atrial tachycardia or atrial flutter [AFL] of unknown origin [all AFL except those Cavotricuspid Isthmus (CTI) dependent AFL as confirmed by 12-lead electrocardiogram or entrainment maneuvers in an EP study]) episodes based on electrocardiographic data (greater than or equal to [>=] 30 seconds on arrhythmia monitoring device) during the effectiveness evaluation period (Day 91 to Day 365) on or off antiarrhythmic therapy. Acute procedural failure: failure to achieve entrance block with the study device in any of the clinically relevant targeted pulmonary veins (PVs). Kaplan-Meier (KM) estimate was used.
Measured: From Day 0 to Day 365 post catheter insertion on Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start12 Sep 2023
- Primary completion10 Dec 2024
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial, Study director, Biosense Webster, Inc., a division of Johnson & Johnson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971693
- Sponsor's protocol ID
- BWI202201
- Other IDs
- BWI202201
- Acronym
- Omny-IRE
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2023
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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
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.
PubMed 40340298