Clinical trial NCT05971693: A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
Official title: Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants with Primary Adverse Events (PAE's)
timeFrame: 7 days post-ablation procedure on Day 0 (up to Day 7)
measure: Percentage of Participants with Acute Effectiveness
timeFrame: Immediate post-procedure
Secondary outcomes:
measure: 12-month Effectiveness: Number of Participants who Achieved Freedom from Documented Atrial Arrhythmia Episodes During the Effectiveness Evaluation period (AF, AT or AFL of Unknown Origin) within Day 91 to Day 365 Post Index Procedure
timeFrame: Within Day 91 to Day 365 post-ablation procedure (on Day 1)
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O L V Ziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Split
country: Croatia
facility: KBC Split
city: Prague
country: Czechia
facility: IKEM
city: Prague
country: Czechia
facility: Nemocnice na Homolce
city: Frankfurt a.M.
country: Germany
facility: MVZ CCB Frankfurt und Main Taunus GbR
city: Acquaviva delle Fonti
country: Italy
facility: Generale Regionale F. Miulli
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
affiliation: Biosense Webster, Inc., a division of Johnson & Johnson
name: Biosense Webster, Inc., a division of Johnson & Johnson Clinical Trial
role: STUDY_DIRECTOR
References: