NCT05971693Completed
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 188 (actual)
- First submitted
- 25 Jul 2023
- Start date
- 12 Sept 2023
- Primary completion date
- 10 Dec 2024
- Lead sponsor
- Biosense Webster, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05971693
What you commit to
- Study type: Interventional
- Participants enrolled: 188
- From 12 Sept 2023 to the primary completion date, 10 Dec 2024
- 13 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrium (LA) ablation or surgery
- Previously diagnosed with persistent AF (\> 7 days in duration)
- 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
- Prior diagnosis of pulmonary vein stenosis
- 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
Other illness
- 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
- 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
- Acute illness, active systemic infection, or sepsis
- 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)
- 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)
- Known uncontrolled significant gastroesophageal reflux disease (GERD)
Lab values
- 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 \[mL/min/1.73 m\^2\])
- Severely compromised left ventricular ejection fraction (left ventricular ejection fraction \[LVEF\] \<40 percentage \[%\])
Age
- 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
Other
- 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)
- 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
- Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
- Pre-existing hemi diaphragmatic paralysis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Severe mitral regurgitation
- Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study
- 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)
- Presence of iron-containing metal fragments in the body
- Known unresolved pre-existing neurological deficit
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZORG Campus Aalst-Moorselbaan Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| Jessa Ziekenhuis - Campus Virga Jesse Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| IKEM Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Nemocnice Na Homolce Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| MVZ CCB Frankfurt und Main Taunus GbR Coordinator of this site? Confirm its status | Frankfurt a.M. | Germany | Unknown status |
| KBC Split Coordinator of this site? Confirm its status | Split | Croatia | Unknown status |
| Generale Regionale F. Miulli Coordinator of this site? Confirm its status | Acquaviva delle Fonti | Italy | Unknown status |
| Vilnius University Hospital Santariškių Klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.