[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565846":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":31,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":54,"whyStopped":31,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"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,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"OLV Hospital","RECRUITING","Aalst","Belgium","9300","BE",{"type":60,"coordinates":61},"Point",[62,63],4.0355,50.93604,{"lat":63,"lon":62},[66],{"name":67,"role":48,"phone":68,"phoneExt":31,"email":69},"Hedwig Batjoens, MSc","+32 53 72 44 49","hedwig.batjoens@olvz-aalst.be",{"type":71,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[73],{"name":74,"class":75},"Biosense Webster, Inc.","INDUSTRY","100565846","evaluation-of-the-impact-of-pulsed-field-ablation-on-autonomic-nervous-system-modulation-in-paroxysmal-atrial-fibrillation-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":88,"type":89},105,"ESTIMATED","INTERVENTIONAL",[92],"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.",[95,96],"Atrial Fibrillation (AF)","Paroxysmal AF",[98,99,100,101,102,103,104],"vagal modulation","ganglionated plexi","pulsed field","dual-energy focal ablation","paroxysmal atrial fibrillation","heart rate variability","pulmonary vein isolation","2025-07-08",{"date":107,"type":108},"2025-07-10","ACTUAL",{"date":110,"type":108},"2025-01-29",{"date":112,"type":89},"2026-12",{"name":5,"class":6},1]