[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565846":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":69,"collaborators":71,"id":75,"slug":31,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":31,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":54,"whyStopped":31,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"VZW Cardiovascular Research Center Aalst","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"PF-only","EXPERIMENTAL","The PF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only PF energy",[13],"Procedure: PF-only PVI",{"label":15,"type":10,"description":16,"interventionNames":17},"Hybrid (PF posterior\u002FRF anterior)","The Hybrid arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using both PF and RF energy",[18],"Procedure: Hybrid PVI",{"label":20,"type":21,"description":22,"interventionNames":23},"RF-only","ACTIVE_COMPARATOR","The RF-only arm includes patients with a clinical indication for ablation to manage their paroxysmal atrial fibrillation, who will undergo PVI using only RF energy",[24],"Procedure: RF-only PVI",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","PF-only PVI","It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only PF energy for ablation",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Hybrid PVI","It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing both PF and RF energy for ablation. Specifically, PF energy is used for the posterior segments and RF energy for the anterior segments of the pulmonary veins",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"RF-only PVI","It consists in performing a point-by-point PVI using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) ablation catheter with the TRUPULSE™ generator, employing only RF energy for ablation",[20],[41],{"name":42,"affiliation":43,"role":44},"Tom De Potter, MD","Cardiovascular Research Center Aalst","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Chiara Valeriano, MD","CONTACT","+34 697539354","chiara.valeriano91@gmail.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":56,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"OLV Hospital","RECRUITING","Aalst","Belgium","9300",{"type":59,"coordinates":60},"Point",[61,62],4.0355,50.93604,{"lat":62,"lon":61},[65],{"name":66,"role":48,"phone":67,"phoneExt":31,"email":68},"Hedwig Batjoens, MSc","+32 53 72 44 49","hedwig.batjoens@olvz-aalst.be",{"type":70,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[72],{"name":73,"class":74},"Biosense Webster, Inc.","INDUSTRY","100565846",false,"NCT06647485","Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation","A Prospective Randomized Study for the Evaluation of the Impact of Point-by-Point Pulse Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation","GPfIRE","Inclusion Criteria:\n\n* Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset\n* Age range: 18-70 years\n* Willing and capable of providing informed consent\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed Persistent AF (\\> 7 days in duration)\n* Previous LA ablation\n* Previous cardiac surgery\n* Myocardial Infarction within the previous 3 months\n* Severely compromised Left Ventricular Ejection Fraction (LVEF\\<40%)\n* Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy\n* Acute illness, active systemic infection, or sepsis\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.\n* Severe mitral regurgitation\n* Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation","ALL","18 Years","70 Years",{"count":86,"type":87},105,"ESTIMATED","INTERVENTIONAL",[90],"NA","The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker. Participants will be randomized into three groups: the PF-only group and the Hybrid group (PF posterior\u002FRF anterior) as the experimental arms, and the RF-only group as the control arm. HRV will be measured before and 24 hours after the PVI procedure. Additionally, cardio and neuro biomarkers (Troponin and S100B) will be measured pre-procedure and 20 minutes post-ablation. All participants will be followed for 12 months, with 24-hour Holter-ECG evaluations scheduled at 3, 6, and 12 months after the initial ablation procedure.",[93,94],"Atrial Fibrillation (AF)","Paroxysmal AF",[96,97,98,99,100,101,102],"vagal modulation","ganglionated plexi","pulsed field","dual-energy focal ablation","paroxysmal atrial fibrillation","heart rate variability","pulmonary vein isolation","2025-07-08",{"date":105,"type":106},"2025-07-10","ACTUAL",{"date":108,"type":106},"2025-01-29",{"date":110,"type":87},"2026-12",{"name":5,"class":6},1]