[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602996":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Cardiocentro Ticino","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","FARAWAVE Nav without pre-ablation CT",[13],"Device: Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","FARAPULSE with pre-ablation CT",[19],"Device: FARAPULSE with pre-ablation CT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT","FARAWAVE Nav without pre-ablation CT (Intervention Group, n = 29)\n\nDescription of the investigation-specific intervention:\n\nParticipants in the intervention group will undergo pulmonary vein isolation (PVI) using the second-generation FARAWAVE Nav pulsed field ablation (PFA) catheter without the use of pre-ablation CT imaging. The FARAWAVE Nav catheter integrates magnetic navigation and electroanatomical mapping capabilities, allowing real-time visualization of left atrial anatomy and electrical signals. Energy delivery is based on non-thermal pulsed electric fields (irreversible electroporation), specifically targeting myocardial tissue while sparing surrounding structures.",[9],null,{"type":22,"name":17,"description":28,"armGroupLabels":29,"otherNames":26},"FARAPULSE with pre-ablation CT (Control Group, n = 29)\n\nDescription of the investigation-specific intervention:\n\nParticipants in the control group will undergo pulmonary vein isolation (PVI) using the first-generation FARAPULSE pulsed field ablation (PFA) catheter. All patients in this group will undergo pre-procedural cardiac CT imaging to evaluate pulmonary vein anatomy and assist in procedural planning. The FARAPULSE catheter delivers non-thermal pulsed electric fields for selective myocardial ablation, aiming to achieve electrical isolation of the pulmonary veins.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Marco Bergonti, MD PhD","CONTACT","+41 (0) 91 811 51 11","bergmar21@gmail.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Cardiocentro Ticino - Ente Ospedaliero Cantonale","RECRUITING","Lugano","Canton Ticino","6900","Switzerland","CH",{"type":46,"coordinates":47},"Point",[48,49],8.96004,46.01008,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":54,"phoneExt":26,"email":35},"Marco Bergonti","091 811 51 11",{"type":56,"investigatorFullName":53,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","MD PhD","100602996","comparative-intra-procedural-evaluation-of-farapulse-and-farawave-nav-catheters-100602996",false,"NCT07130773","Comparative Intra-procedural Evaluation of Farapulse and FARAWAVE Nav Catheters","Procedural Comparative Evaluation of Pulmonary Vein Isolation Using the FARAWAVE Nav PFA Catheter Without Pre-Ablation Computer Tomography (CT) vs. Conventional Farapulse With Pre-Ablation CT: A Single Centre Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Atrial fibrillation (AF) documented on a 12-lead ECG, Holter monitor, or implantable cardiac device.\n* Candidate for ablation according to current atrial fibrillation guidelines.\n* Age ≥18 years at the time of informed consent.\n* Signed informed consent obtained\n\nExclusion Criteria:\n\n* Previous left atrial ablation or left atrial surgery.\n* Presence of intracardiac thrombus.\n* Persistent atrial fibrillation lasting \\>3 years.\n* Severe mitral regurgitation or moderate-to-severe mitral stenosis.\n* Pregnancy (all women under 50 years undergo an HCG blood test prior to inclusion to exclude pregnancy).","ALL","18 Years",{"count":68,"type":69},58,"ESTIMATED","INTERVENTIONAL",[72],"NA","The FARAPULSE PFA catheter (Boston Scientific), a first-generation Pulsed Field Ablation (PFA) tool, has demonstrated good performance in isolating pulmonary veins (PV). Several centers, including ours, utilize pre-procedural computer tomography (CT) to evaluate individual pulmonary vein anatomy and optimize ablation planning. However, these imaging modalities are costly. Additionally, CT imaging exposes patients to radiation, and introduce significant logistical challenges to the procedural workflow.\n\nThe FARAWAVE Nav PFA catheter, a second-generation device, integrates magnetic navigation capabilities with detailed mapping and PFA therapy into a single tool. This system leverages the FARAVIEW Software Module, offering tailored mapping solutions visualized on the FARAPULSE PFA system, including the creation of voltage and activation maps.\n\nThese features address the limitations of the first-generation FARAPULSE catheter and have the potential to improve procedural accuracy and the durability of pulmonary vein isolation. Moreover, they may obviate the need for pre-procedural CT, thereby reducing costs and minimizing patient radiation exposure.\n\nOur study evaluates whether the FARAWAVE Nav catheter, used without pre-ablation CT, allows for a reduction in fluoroscopy time and overall patient radiation exposure compared to the conventional workflow with the FARAPULSE catheter. Furthermore, we will assess procedural time, costs, number of PFA applications, and AF recurrence-free survival",[75,76,77],"Atrial Fibrillation (AF)","Atrial Fibrillation Ablation","Pulsed Field Ablation",[79,80,81,82,83,84,85,86],"pulsed filed ablation","atrial fibrillation","ablation","pulmonary vein isolation","electroanatomical map","ionizing radiation","farapulse","farawave nav","2026-03-17",{"date":89,"type":90},"2026-03-19","ACTUAL",{"date":92,"type":90},"2025-11-10",{"date":94,"type":69},"2026-12",{"name":5,"class":6},1]