Phase
Condition
Chest Pain
Atrial Fibrillation
Cardiac Disease
Treatment
OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF) defined as as atrialfibrillation (AF) that terminates spontaneously or with intervention within 7 daysof onset. This PAF is considered to be symptomatic if symptoms related to AF areexperienced 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 andrequirements
Exclusion
Exclusion Criteria:
Previously known AF secondary to electrolyte imbalance, thyroid disease, orreversible or non-cardiac cause (example, documented obstructive sleep apnea, acutealcohol toxicity, morbid obesity [body mass index greater than {>} 40 kilograms permeter square {kg/m^2}]), renal insufficiency (with an estimated creatinine clearanceless 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] >50millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
Presence of LA thrombus
Severely compromised left ventricular ejection fraction (left ventricular ejectionfraction [LVEF] <40 percentage [%])
Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
History of blood clotting, bleeding abnormalities or contraindication toanticoagulation (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 valvularsurgery, 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 withinthe next 12 months
Significant pulmonary disease (example, restrictive pulmonary disease, constrictiveor chronic obstructive pulmonary disease) or any other disease or malfunction of thelungs or respiratory system that produces severe chronic symptoms
Known significant pulmonary vein (PV) anomaly that in the opinion of theinvestigator 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 orother abnormality that precludes catheter introduction or manipulation
Severe mitral regurgitation
Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD) orother implanted metal cardiac device that may interfere with the pulsed electricfield 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 theinvestigator would preclude enrollment in this study
Categorized as vulnerable population and requires special treatment with respect tosafeguards 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 thecourse of the clinical investigation
Life expectancy less than 12 months
Presenting contra-indications for the devices used in the study, as indicated in therespective Instructions For Use (IFU)
Known contraindication for magnetic resonance imaging (MRI) such as use of contrastagents due to advanced renal disease, claustrophobia etcetra. (at principleinvestigator [PI] discretion)
Presence of iron-containing metal fragments in the body
Known unresolved pre-existing neurological deficit
Known uncontrolled significant gastroesophageal reflux disease (GERD)
Study Design
Connect with a study center
O L V Ziekenhuis
Aalst, 9300
BelgiumSite Not Available
O.L.V. Ziekenhuis
Aalst, 9300
BelgiumActive - Recruiting
AZ Sint-Jan
Brugge, 8000
BelgiumSite Not Available
Ziekenhuis Oost-Limburg
Genk, 3600
BelgiumSite Not Available
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
BelgiumSite Not Available
McGill University Health Centre
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
KBC Split
Split, 21000
CroatiaSite Not Available
IKEM
Prague, 140 21
CzechiaSite Not Available
Nemocnice na Homolce
Prague, 150 30 District 5
CzechiaSite Not Available
MVZ CCB Frankfurt und Main Taunus GbR
Frankfurt a.M., 60431
GermanySite Not Available
Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021
ItalySite Not Available
Vilnius University
Vilnius, 08661
LithuaniaSite Not Available
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661
LithuaniaSite Not Available
Maastricht UMC
Maastricht, 6229 HX
NetherlandsSite Not Available
Maastricht UMC+
Maastricht, 6229 HX
NetherlandsActive - Recruiting
Luzerner Kantonsspital
Luzern 16, 6000
SwitzerlandSite Not Available
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