[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579795":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"CardioFocus","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System",[13],"Device: pulsed field ablation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","pulsed field ablation","Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Vikramaditya Mediratta, MS","CONTACT","714-717-2376","vmediratta@cardiofocus.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Lisa Hausmann, MPH","508-658-7253","lhausmann@cardiofocus.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":20,"country":37,"countryCode":20,"cosmosGeoPoint":38,"geoPoint":43,"contacts":20},"Na Homolce Hospital","RECRUITING","Prague","Czech Republic","Czechia",{"type":39,"coordinates":40},"Point",[41,42],14.42076,50.08804,{"lat":42,"lon":41},{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100579795","pulmonary-vein-isolation-with-the-single-shot-endoscopic-ultra-compliant-pfa-balloon-for-the-treatment-of-af-100579795",false,"NCT06828939","Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF","Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation","VISION AF","Inclusion Criteria:\n\n* Recurrent symptomatic PAF with at least one documented episode\n* Failure or intolerance of at least one AAD\n* Age 18-75 years\n* Patient is indicated for an ablation procedure according to society guidelines or study site practice\n* Patient is willing and able to give informed consent\u002Fparticipate in baseline and follow-up assessments for the duration of the study\n\nExclusion Criteria:\n\n* overall good health as established by multiple criteria","ALL","18 Years","75 Years",{"count":58,"type":59},75,"ESTIMATED","INTERVENTIONAL",[62],"NA","This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.",[65],"Atrial Fibrillation (Paroxysmal)",[67,17],"ablation","2025-10-02",{"date":70,"type":71},"2025-10-07","ACTUAL",{"date":73,"type":71},"2024-12-12",{"date":75,"type":59},"2026-05-31",{"name":5,"class":6},1]