Status:
COMPLETED
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 v...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2025
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT05971693
Start Date
September 12 2023
End Date
September 5 2025
Last Update
October 14 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
AZORG campus Aalst Moorselbaan
Aalst, Belgium, 9300
2
AZ Sint-Jan
Bruges, Belgium, 8000
3
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
4
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium, 3500