[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558957":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulmonary vein isolation by pulse field ablation","ACTIVE_COMPARATOR",null,[13],"Procedure: Pulmonary vein isolation by pulse field ablation",{"label":15,"type":10,"description":11,"interventionNames":16},"Pulmonary vein isolation by cryoablation",[17],"Procedure: Pulmonary vein isolation by cryoablation",[19,23],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":11},"PROCEDURE","Pulse Field Ablation (PFA) is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes.",[9],{"type":20,"name":15,"description":24,"armGroupLabels":25,"otherNames":11},"Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device.",[15],[27],{"name":28,"affiliation":5,"role":29},"Marine CAMUS","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Mikael Laredo, MD, PhD","CONTACT","+33184827620","mikael.laredo@aphp.fr",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":41,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Dr Mikael Laredo","RECRUITING","Paris","France","75013","FR",{"type":45,"coordinates":46},"Point",[47,48],2.3488,48.85341,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":34,"phoneExt":11,"email":35},"LAREDO",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100558957","the-effect-of-pulse-field-ablation-on-atrial-mechanics-in-catheter-ablation-of-paroxysmal-atrial-fibrillation-100558957",false,"NCT06557876","The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation","The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation","PF-MRI","Inclusion Criteria:\n\n* Patient age ≥ 18\n* Established diagnosis of paroxysmal fibrillation, with a I\u002FIIa\u002FIIb indication for catheter ablation (ESC 2020 guidelines)\n* Episode of AF documented by ECG within the last 12 months\n* Patient able to give written informed consent\n* If female of childbearing potential, have a negative serum pregnancy test and using effective contraception\n* Be affiliated with a French social security system or entitled\n\nExclusion Criteria:\n\n* Non-paroxysmal atrial fibrillation\n* Contraindication to oral anticoagulation\n* Intracardiac thrombus\n* Previous ablation in the left atrium\n* Previous heart surgery\n* Significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis\n* Contraindication to perform MRI or using the DOTAREM™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with GFR \\\u003C 30 mL\u002Fmin, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia)\n* Patient on AME (state medical aid)\n* Pregnant or breast-feeding female\n* Patient protected by law (guardianship, tutelage measure, deprived of liberty)\n* Participation in another interventional study or being in the exclusion period at the end of a previous study.","ALL","18 Years",{"count":66,"type":67},80,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is:\n\n• Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ?\n\nParticipants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months.\n\nResearchers will compare 2 arms:\n\n* Pulse-Field Ablation\n* Cryoablation",[73],"Atrial Fibrillation Paroxysmal","2026-05-29",{"date":76,"type":77},"2026-06-02","ACTUAL",{"date":79,"type":77},"2024-10-09",{"date":81,"type":67},"2026-10-01",{"name":5,"class":6},1]