New heart catheter shows promise for AFib patients
NCT ID NCT05971693
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device called the OMNYPULSE catheter with the TRUPULSE generator to treat paroxysmal atrial fibrillation (a type of irregular heartbeat). The goal was to see if it is safe and effective at isolating the veins that carry blood from the lungs to the heart. 188 participants with symptomatic AFib were enrolled. The study measured safety events within 7 days and how well the procedure stopped abnormal electrical signals.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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188 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Sint-Jan
Bruges, 8000, Belgium
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AZORG campus Aalst Moorselbaan
Aalst, 9300, Belgium
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Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021, Italy
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IKEM
Prague, 140 21, Czechia
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Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
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KBC Split
Split, 21000, Croatia
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MVZ CCB Frankfurt und Main Taunus GbR
Frankfurt a.M., 60431, Germany
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Maastricht UMC
Maastricht, 6229 HX, Netherlands
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McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
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Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
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Nemocnice na Homolce
Prague, 150 30 District 5, Czechia
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Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661, Lithuania
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Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
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