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

NCT05971693 | Completed Results DMC FDA Device

• 1 other identifier: BWI202201
• Study Type: interventional
• Target: 188
• Locations: 8 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

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).

Device: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator

Interventions

OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator 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).

OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (13)

AZORG campus Aalst Moorselbaan

Aalst, 9300, Belgium

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

KBC Split

Split, 21000, Croatia

Location

IKEM

Prague, 140 21, Czechia

Location

Nemocnice na Homolce

Prague, 150 30 District 5, Czechia

Location

MVZ CCB Frankfurt und Main Taunus GbR

Frankfurt a.M., 60431, Germany

Location

Generale Regionale F. Miulli

Acquaviva delle Fonti, 70021, Italy

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

Location

Maastricht UMC

Maastricht, 6229 HX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40340298 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Executive Medical Director
• Organization: Janssen Research and Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: September 12, 2023
• Primary Completion: December 10, 2024
• Study Completion: September 5, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (2); CZ (2); CR (1); IT (1); LI (1); DE (1); BE (4); NL (1)