Phase
Condition
Chest Pain
Arrhythmia
Dysrhythmia
Treatment
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) defined 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)
Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced byrecurrent symptomatic AF, or intolerable or contraindicated to the AAD
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/m²]}, renal insufficiency (with an estimated creatinine clearanceless than [<] 30 milliliters [mL]/ minute [min]/1.73 meter square [m2] )
Previous left atrium (LA) ablation or surgery
Patients known to require ablation outside the pulmonary vein (PV) region (example,atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia,atrial tachycardia, ventricular tachycardia and wolff-parkinson-white)
Previously diagnosed with persistent AF [greater than (>) 7 days in duration]
Severe dilatation of the left atrium (LA) (Left anterior descending artery [LAD] >50mm antero-posterior diameter in case of Transthoracic Echocardiography [TTE])
Study Design
Connect with a study center
Medical University Graz
Graz, 8036
AustriaSite Not Available
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
AustriaSite Not Available
O L V Ziekenhuis
Aalst, 9300
BelgiumSite Not Available
O.L.V. Ziekenhuis
Aalst, 9300
BelgiumSite Not Available
AZ Sint-Jan
Brugge, 8000
BelgiumSite Not Available
Ziekenhuis Oost-Limburg
Genk, 3600
BelgiumSite Not Available
Jessa Ziekenhuis
Hasselt, 3500
BelgiumSite Not Available
Aarhus University Hospital
Aarhus, 8200
DenmarkSite Not Available
Gentofte Hospital
Hellerup, 2900
DenmarkSite Not Available
Odense University Hospital
Odense C, 5000
DenmarkSite Not Available
Vilnius University Hospital Santaros Clinics
Vilnius, 08661
LithuaniaSite Not Available

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