protocolSection identificationModule nctId: NCT06296888, orgStudyIdInfo id: P-2022-673, secondaryIdInfos id: 2203718, type: OTHER, domain: De Videnskabsetiske Medicinske Komiteer, briefTitle: Radiofrequency Balloon Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolated and Clinical Outome, acronym: RABAAF, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-08-09, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Jim Hansen, class: OTHER, collaborators name: University Hospital, Gentofte, Copenhagen, collaborators name: Biosense Webster, Inc., descriptionModule briefSummary: Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: Radiofrequency balloon catheter ablation, outcomesModule primaryOutcomes measure: Proportion of durably isolated PVs observed at repeat EP study, secondaryOutcomes measure: Proportion of patients with durable isolation of all PVs observed at repeat EP study, secondaryOutcomes measure: Proportion of patients remaining free from recurrence of ATA after the initial PVI, secondaryOutcomes measure: Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI, secondaryOutcomes measure: Complications, otherOutcomes measure: Proportion of patients remaining free from recurrence of ATA after the repeat EP study, otherOutcomes measure: Difference in the effect of AF related symptoms on quality of life between baseline, after the initial PVI, and after the repeat EP study, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gentofte Hospital, city: Hellerup, zip: 2820, country: Denmark, geoPoint lat: 55.73204, lon: 12.57093, hasResults: False