[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583482":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":48,"collaborators":20,"id":50,"slug":20,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Accuryn Foley catheter placement","EXPERIMENTAL","foley catheter is made to measure intra-abdominal pressure",[13],"Device: Accuryn Foley catheter device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Accuryn Foley catheter device","Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Karuna Rajkumar, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","832-707-0858","kputturr@wakehealth.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Wake Forest Health Sciences","RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-80.24422,36.09986,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":28,"phoneExt":20,"email":29},"Karuna Rajkumar",{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100583482",false,"NCT06876896","Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib\u002F A-Flutter","Comparative Study of Intra-abdominal Pressure Using Accuryn Monitoring System During Pulsed Field Ablation (PFA) for Treatment of Atrial Fibrillation and\u002For Atrial Flutter Under Sedation.","IAP","Inclusion Criteria:\n\n* Adult patients receiving pulse field ablation procedures for standard of care treatment of atrial fibrillation and\u002For atrial flutter.\n* Eligible for Foley catheter placement with no contraindications to Intra-abdominal pressure (IAP) monitoring.\n\nExclusion Criteria:\n\n* Patients under the age of 18 will be excluded.\n* History of intra-abdominal surgery within the past 6 months.\n* Known contraindications to bladder catheterization or catheter ablation; history of prostate issues \u002F Benign prostatic hyperplasia (BPH) or frequent urinary tract infections\n* Pregnant or breastfeeding individuals\n* History of chronic obstructive pulmonary disease (COPD) with home oxygen use","ALL","18 Years",{"count":60,"type":61},50,"ESTIMATED","INTERVENTIONAL",[64],"NA","The purpose of this study is to investigate the intra-abdominal pressure utilizing the Accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.",[67],"Intra-Abdominal Hypertension",[69,70,71],"Atrial Fibrillation","Atrial Flutter","Pulsed Field Ablation","2026-03-18",{"date":74,"type":75},"2026-03-19","ACTUAL",{"date":77,"type":75},"2026-03-03",{"date":79,"type":61},"2026-12-30",{"name":5,"class":6},1]