[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520210":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Wroclaw Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"expandable cryoballoon","EXPERIMENTAL","POLARxFIT",[13],"Device: cryoablation of atrial fibrillation using expandable balloon (28 \u002F 31 mm)",{"label":15,"type":10,"description":16,"interventionNames":17},"standard cryoballoon","POLARx",[18],"Device: cryoablation of atrial fibrillation using only 28 mm size balloon",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","cryoablation of atrial fibrillation using only 28 mm size balloon","all applications in all PVs are done with 28 mm balloon",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"cryoablation of atrial fibrillation using expandable balloon (28 \u002F 31 mm)","first applications in LSPV and RSPV are done with 31 mm balloon",[9],[31],{"name":32,"affiliation":5,"role":33},"Piotr Niewinski, MD, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+48 71 733 1112","piotr.niewinski@umw.edu.pl",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Institute of Heart Diseases, Wroclaw Medical University","RECRUITING","Wroclaw","Lower Silesian Voivodeship","50-556","Poland","PL",{"type":49,"coordinates":50},"Point",[51,52],17.03006,51.10286,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":58},"Piotr Niewinski, PhD","790423298","pnsky@wp.pl",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Piotr Niewinski, MD","Principal Investigator",[63],{"name":64,"class":65},"Boston Scientific Corporation","INDUSTRY","100520210","the-impact-of-expandable-cryoballoon-on-autonomic-control-of-the-heart-100520210",false,"NCT06053606","The Impact of Expandable Cryoballoon on Autonomic Control of the Heart","The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart","Inclusion Criteria:\n\n* primary PVI\n* paroxysmal atrial fibrillation\n* sinus rhythm at the admission\n* participant meets clinical criteria for PVI\n\nExclusion Criteria:\n\n* LA diameter \\\u003C38 mm or \\>50 mm\n* LVEF \\\u003C40%\n* intrinsic sinus node disease\n* advanced atrioventricular block (PR interval \\>300 ms, II or III degree AV block)\n* previous cardioneuroablation procedure\n* pregnancy\n* contraindications to anticoagulation treatment\n* any other clinical contraindications to PVI\n* known atropine intolerance","ALL","18 Years","79 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.",[84],"Paroxysmal Atrial Fibrillation",[86,87,88,89,90,91],"atrial fibrillation","ganglionated plexus","autonomic modulation","cryoablation","cryoballoon","expandable balloon","2025-07-20",{"date":94,"type":95},"2025-07-24","ACTUAL",{"date":97,"type":95},"2024-05-10",{"date":99,"type":78},"2026-12-31",{"name":5,"class":6},1]