[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641807":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":16,"centralContacts":21,"locations":30,"responsibleParty":72,"collaborators":7,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":7,"enrollmentInfo":84,"targetDuration":7,"studyType":87,"phases":7,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Volta Medical","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Cardiac mapping","All patients enrolled are treated for their atrial fibrillation\u002Ftachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II, used in accordance with its approved indication as per of its IFU) during the mapping phase to identify areas of interest specific to the patient.\n\nThe ablation approach is free and chosen by the operator according to his standard practice. The two main phases of the ablation procedure are:\n\n* 3D mapping of the atria and location of areas of interest;\n* Catheter ablation at the operator's discretion.",[14,15],"Atrial fibrillation mapping","Ablation procedure",[17],{"name":18,"affiliation":19,"role":20},"Clément BARS, MD","Hôpital Saint Joseph Marseille","PRINCIPAL_INVESTIGATOR",[22,27],{"name":23,"role":24,"phone":25,"phoneExt":7,"email":26},"Paola MILPIED","CONTACT","+33768025499","paola.milpied@volta-medical.com",{"name":28,"role":24,"phone":7,"phoneExt":7,"email":29},"Cecile BIELMANN","cecile.bielmann@volta-medical.com",[31,47,60],{"facility":32,"status":33,"city":34,"state":7,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hôpital Saint-Joseph Marseille","RECRUITING","Marseille","13008","France","FR",{"type":39,"coordinates":40},"Point",[41,42],5.38107,43.29695,{"lat":42,"lon":41},[45],{"name":46,"role":24,"phone":7,"phoneExt":7,"email":7},"Clément Bars, MD",{"facility":48,"status":49,"city":50,"state":7,"zip":51,"country":36,"countryCode":37,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Centre Cardiologique du Nord","NOT_YET_RECRUITING","Saint-Denis","93207",{"type":39,"coordinates":53},[54,55],2.35387,48.93564,{"lat":55,"lon":54},[58],{"name":59,"role":24,"phone":7,"phoneExt":7,"email":7},"Antoine Lepillier, MD",{"facility":61,"status":49,"city":62,"state":7,"zip":63,"country":36,"countryCode":37,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Clinique Rhéna","Strasbourg","67000",{"type":39,"coordinates":65},[66,67],7.74553,48.58392,{"lat":67,"lon":66},[70],{"name":71,"role":24,"phone":7,"phoneExt":7,"email":7},"Babé Bakouboula, MD",{"type":73,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100641807","volta-medical-ai-software-in-real-world-during-af-ablation-100641807",false,"NCT07621055","VOLta Medical AI-software in REal-World During AF Ablation","Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies","VOLTAIRE-AF","Inclusion Criteria:\n\n1. Patient aged 18 years or older.\n2. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II.\n3. Patient able and willing to provide written informed consent to participate in the study.\n4. Only for France: Patient affiliated to the French social security system.\n\nExclusion Criteria:\n\n1. Contraindication to AF\u002FAT catheter ablation using RF and\u002For PFA.\n2. Patient who is or could potentially be pregnant.\n3. Person deprived of liberty or under guardianship.\n4. Person unable to undergo a medical monitoring for geographical, social or psychological reasons.\n5. Patient's refusal to participate in the study.\n6. Enrollment in a premarket clinical study evaluating device, drug or biologic product.","ALL","18 Years",{"count":85,"type":86},150,"ESTIMATED","OBSERVATIONAL","This PMCF study \"VOLTAIRE-AF\" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in \"real life\"clinical practice, without any imposed clinical workflow.",[90,91,92],"Atrial Fibrillation","Atrial Arrhythmia","Arrhythmias, Cardiac",[94,95,96,97,98,5,91],"Volta AF-Xplorer II","Artificial Intelligence","Cardiac ablation","Medical Device","Software","2026-06-17",{"date":101,"type":102},"2026-06-22","ACTUAL",{"date":104,"type":102},"2026-06-16",{"date":106,"type":86},"2030-06",{"name":5,"class":6},3]