[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637198":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":18,"responsibleParty":42,"collaborators":44,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":71,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":18},{"fullName":5,"class":6},"Asklepios proresearch","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group1: Pulsed Field-Ablation","ACTIVE_COMPARATOR","Patients randomized in the intervention group should receive the PFA ablation within 21 days.",[13],"Procedure: Ablation of atrial fibrillation (AF)",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: Usual care","NO_INTERVENTION","Patients randomized in the control group \u002F usual care group will undergo optimal medical treatment (OMT), defined as antiarrhythmic drug therapy (AAD). Within 21 days patients in the control group should start or maintain on AAD therapy based on decision of the investigator and according to current ESC Guidelines.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Ablation of atrial fibrillation (AF)","PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Arian Sultan, MD, PhD","Asklepios Klinik St. Georg","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":29},"Stephan Willems, MD, PhD",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Kathrin Heitmann","CONTACT","+49 40 181885","5406","ka.heitmann@asklepios.com",{"name":40,"role":35,"phone":36,"phoneExt":37,"email":41},"Nele Gessler, MD, PhD","n.gessler@asklepios.com",{"type":43,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[45,48],{"name":46,"class":47},"Atrial Fibrillation Network","OTHER",{"name":49,"class":6},"Abbott","100637198","pulsed-field-ablation-for-atrial-fibrillation-using-a-balloon-for-early-intervention---study-100637198",false,"NCT07621003","PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study","PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The \"PULSE - Study\"","PULSE","Inclusion Criteria:\n\n* Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation\n* First diagnosis of AF within the last 36 months\n* At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device\n* No prior catheter ablation for AF\n\nExclusion Criteria:\n\n* Persistent AF \\>3 years or longstanding persistent AF\n* Previous AF-Ablation\n* Ongoing continuous AAD therapy with Amiodarone at baseline\n* History of failed continuous AAD therapy with \\> 1 agent. Exceptions are Beta blocker, Verapamil or \"pill in the pocket\"-therapy\n* Left Atrial Volume Index (LAVI) \\> 50mL\u002Fm2\n* Severe mitral regurgitation\n* Contraindications to anticoagulation therapy\n* Severe pulmonary or renal disease\n* Pregnancy, active cancer disease\n* Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD)","ALL","18 Years",{"count":61,"type":62},264,"ESTIMATED","INTERVENTIONAL",[65],"NA","This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage paroxysmal or persistent atrial fibrillation (\\\u003C3 years) compared to usual care, defined as OMT.",[68],"Atrial Fibrillation",[70],"Ablation","NOT_YET_RECRUITING","2026-05-27",{"date":74,"type":75},"2026-06-02","ACTUAL",{"date":77,"type":62},"2026-07-01",{"date":79,"type":62},"2031-03-31",{"name":5,"class":6}]