[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459608":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":63,"studyPopulation":54,"armGroups":64,"interventions":77,"overallOfficials":86,"centralContacts":90,"locations":97,"responsibleParty":256,"collaborators":54,"id":258,"slug":54,"hasResults":259,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":259,"sex":265,"minAge":266,"maxAge":267,"enrollmentInfo":268,"targetDuration":54,"studyType":271,"phases":272,"briefSummary":274,"conditions":275,"keywords":54,"overallStatus":100,"whyStopped":54,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},{"fullName":5,"class":6},"Elsan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"1-year sinus rhythm maintenance rate","Rate of patients with sinus rhythm (yes\u002Fno) at 1 year after a single ablative procedure","At 1 year after ablation",[14,17,19,21,24,26,28,31,35,39,43,46,50],{"measure":15,"description":16,"timeFrame":12},"Rate of patients with sinus rhythm (randomized patients)","Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.",{"measure":18,"description":16,"timeFrame":12},"Rate of patients with sinus rhythm (registry patients)",{"measure":20,"description":16,"timeFrame":12},"Rate of patients with sinus rhythm (randomized and registry patients, strategy PVI procedure alone)",{"measure":22,"description":22,"timeFrame":23},"Duration (in minutes) of ablative procedure","On the day of the ablative procedure",{"measure":25,"description":25,"timeFrame":23},"Duration (in minutes) of radiofrequency use",{"measure":27,"description":27,"timeFrame":23},"Duration (in minutes) of Fluoroscopy",{"measure":29,"description":29,"timeFrame":30},"Duration (in days) of hospitalization","From date of surgery until the date of discharge from hospital assessed up to 1 day",{"measure":32,"description":33,"timeFrame":34},"Evaluation of major complications rate","Tamponade and\u002For stroke rate out of the blanking period and up to 1-year follow-up","Up to 1 year",{"measure":36,"description":37,"timeFrame":38},"Evaluation of drug treatment use rate or electric cardioversion in the blanking period","Number of patients using drug treatment and\u002For electric cardioversion during the blanking period (first 3 months after ablation) between the two strategies (randomized patients)","At three months after ablation",{"measure":40,"description":41,"timeFrame":42},"Evaluation of the minor complications rate between the two strategies after 1-year follow-up (randomized patients)","Occurrence of a false aneurysm or fistulas at the puncture sites and\u002For occurrence of a post-ablation pericardial reaction","up to 1-year follow-up",{"measure":44,"description":45,"timeFrame":42},"Evaluation of the vein isolation as well as other linear lesions in patients with recurrence of atrial fibrillation during 1 year after ablation","Pulmonary vein isolation as well as other linear lesions block assessment during redo procedures",{"measure":47,"description":48,"timeFrame":49},"Evaluation of the impact of low voltage areas on the response to EC prior to catheter ablation","Relationship between the presence or absence of LA low voltage areas and the response to EC prior to catheter ablation Relationship between the extent of LA low voltage areas and the response to EC prior to catheter ablation Relationship between the location of LA low voltage areas and the response to EC prior to catheter ablation","catheter ablation",{"measure":51,"description":52,"timeFrame":53},"Evaluation of the impact of low voltage areas on the success of the ablation procedure","Relationship between the presence or absence of LA low voltage areas and the success of the ablation procedure Relationship between the extent of LA low voltage areas and the success of the ablation procedure Relationship between the location of LA low voltage areas and the success of the ablation procedure","ablation procedure",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":54,"timePerspective":54,"maskingInfo":60},"RANDOMIZED","PARALLEL","The study procedure is the electric cardioversion as a discriminant factor between patients requiring PVI procedure alone or PVI procedure combined with substrate modulation. This electric cardioversion will be performed in all included patients up to 6 weeks before the ablative procedure.\n\nOn the day of the ablative procedure:\n\n* If the patient presents with a Sinus Rhythm (= successful electric cardioversion, approximately 70% of patients) the patient will be treated as per SoC in accordance with ESC recommendations. It is recommended to perform PVI procedure alone in these patients. A prospective registry for these patients will be established for this study.\n* If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to the 2 strategies:\n* Group 1: PVI procedure alone in accordance with ESC recommendations\n* Group 2: PVI procedure associated with substrate modulation","TREATMENT",{"masking":61,"maskingDescription":62,"whoMasked":54},"NONE","N\u002FA, open label.","Atrial fibrillation (AF) is the most common heart rhythm disorder. It is the result of uncoordinated action of the atrial myocardial cells, causing rapid and irregular contraction of the heart's atria.\n\nThe AF prevalence in adults is currently estimated to be between 2% and 4% and is expected to increase by a factor of 2.3 in the next few years, due to the increased longevity of the general population and the increased search for undiagnosed AF. Increased age is an important risk factor for AF, but other increased comorbidities, including hypertension, diabetes, heart failure, coronary artery disease, chronic renal failure, obesity, and obstructive sleep apnoea syndrome, are also important; modifiable risk factors contribute strongly to the development and progression of AF (ESC Guideline, 2020).\n\nThe European Society of Cardiology (ESC) recommended pulmonary vein isolation (PVI) (Class IA) as first-line ablative strategy for persistent AF (Class IA) (ESC Guideline, 2020). However, PVI alone is only effective in treating about 40% to 60% of patients with persistent AF in the general population (unselected). If we apply this strategy to all patients (PVI alone), we accept to re-do ablative procedure in up to 60% of patients.\n\nThe second feasible strategy is to treat patients with persistent AF by PVI combined with substrate modulation (ESC Class IIb). This strategy, when done well, by creating irreversible lesions (Marshall-PLAN) can effectively treat 70% to 80% of AF patients. But this implies that the investigator will be doing unnecessary substrate modulation in up to 40% of patients, which can lead to increased risks associated with the ablative procedure, longer procedure times, multiple lesions, etc… In addition, incorrect or incomplete substrate modulation is pro-arrhythmic and leads to recurrences in the form of left atrial flutters, tolerance of which, is generally poor.\n\nBoth ablative strategies have been widely validated in large numbers of published studies.\n\nThe problem is to know when and for which patients to apply one or the other of the two strategies. Electric cardioversion could help in selecting the most appropriate strategy.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"PVI procedure alone","ACTIVE_COMPARATOR","If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to :\n\n\\- Group 1: PVI procedure alone in accordance with ESC recommendations",[70],"Procedure: Pulmonary Vein Isolation (PVI) alone",{"label":72,"type":73,"description":74,"interventionNames":75},"PVI procedure combined with substrate modulation","EXPERIMENTAL","If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to :\n\n\\- Group 2: PVI procedure associated with substrate modulation",[76],"Procedure: PVI procedure associated with substrate modulation",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":54},"PROCEDURE","Pulmonary Vein Isolation (PVI) alone","PVI procedures correspond to point-by-point 50W AI-guided RF applications (400 posterior LA wall, and 550 elsewhere). The PVI will be validated by the absence of any activity recorded inside the PV encirclement by a multipolar catheter (either a Lasso catheter or a Pentaray catheter) (entrance block) and by the non-capture of the LA despite pacing maneuvers from inside the encirclement (exit block). The bidirectional block will be validated again after a 15-minutes waiting period.",[66],{"type":79,"name":84,"description":84,"armGroupLabels":85,"otherNames":54},"PVI procedure associated with substrate modulation",[72],[87],{"name":88,"affiliation":5,"role":89},"Augustin Bortone, MD","STUDY_DIRECTOR",[91],{"name":92,"role":93,"phone":94,"phoneExt":95,"email":96},"Agustín Bortone, MD","CONTACT","04 66 26 63 75","+33","agubene@hotmail.com",[98,114,127,137,149,161,172,184,196,208,220,232,244],{"facility":99,"status":100,"city":101,"state":54,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Infirmerie Protestante","RECRUITING","Caluire-et-Cuire","69300","France","FR",{"type":106,"coordinates":107},"Point",[108,109],4.8464,45.79462,{"lat":109,"lon":108},[112],{"name":113,"role":93,"phone":54,"phoneExt":54,"email":54},"Cyril Durand, MD",{"facility":115,"status":116,"city":117,"state":54,"zip":118,"country":103,"countryCode":104,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"CH Libourne","NOT_YET_RECRUITING","Libourne","33500",{"type":106,"coordinates":120},[121,122],-0.24186,44.91449,{"lat":122,"lon":121},[125],{"name":126,"role":93,"phone":54,"phoneExt":54,"email":54},"Rim EL BOUAZZAOUI, MD",{"facility":128,"status":129,"city":130,"state":54,"zip":131,"country":103,"countryCode":104,"cosmosGeoPoint":132,"geoPoint":136,"contacts":54},"CHU Lille","ACTIVE_NOT_RECRUITING","Lille","59000",{"type":106,"coordinates":133},[134,135],3.05512,50.63391,{"lat":135,"lon":134},{"facility":138,"status":116,"city":139,"state":54,"zip":140,"country":103,"countryCode":104,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hopital ST Phillbert","Lomme","59462",{"type":106,"coordinates":142},[143,144],2.98715,50.64358,{"lat":144,"lon":143},[147],{"name":148,"role":93,"phone":54,"phoneExt":54,"email":54},"Yves Guyomar, MD",{"facility":150,"status":116,"city":151,"state":54,"zip":152,"country":103,"countryCode":104,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"CMC Ambroise Paré Hartmann","Neuilly-sur-Seine","92200",{"type":106,"coordinates":154},[155,156],2.26965,48.8846,{"lat":156,"lon":155},[159],{"name":160,"role":93,"phone":54,"phoneExt":54,"email":54},"Alexandre Zhao, MD",{"facility":162,"status":100,"city":163,"state":54,"zip":164,"country":103,"countryCode":104,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Hôpital Privé Les Franciscaines","Nîmes","30000",{"type":106,"coordinates":166},[167,168],4.35788,43.83665,{"lat":168,"lon":167},[171],{"name":92,"role":93,"phone":54,"phoneExt":54,"email":96},{"facility":173,"status":100,"city":174,"state":54,"zip":175,"country":103,"countryCode":104,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie","Paris","75015",{"type":106,"coordinates":177},[178,179],2.3488,48.85341,{"lat":179,"lon":178},[182],{"name":183,"role":93,"phone":54,"phoneExt":54,"email":54},"Emilie Varlet, MD",{"facility":185,"status":100,"city":186,"state":54,"zip":187,"country":103,"countryCode":104,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Clinique St Pierre Cardiologie","Perpignan","66000",{"type":106,"coordinates":189},[190,191],2.89541,42.69764,{"lat":191,"lon":190},[194],{"name":195,"role":93,"phone":54,"phoneExt":54,"email":54},"Philippe Lagrange, MD",{"facility":197,"status":100,"city":198,"state":54,"zip":199,"country":103,"countryCode":104,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"CHU Rennes","Rennes","35033",{"type":106,"coordinates":201},[202,203],-1.67431,48.11109,{"lat":203,"lon":202},[206],{"name":207,"role":93,"phone":54,"phoneExt":54,"email":54},"Raphael Martins, MD",{"facility":209,"status":116,"city":210,"state":54,"zip":211,"country":103,"countryCode":104,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"CCN","Saint-Denis","93200",{"type":106,"coordinates":213},[214,215],2.35387,48.93564,{"lat":215,"lon":214},[218],{"name":219,"role":93,"phone":54,"phoneExt":54,"email":54},"Antoine Lepillier, MD",{"facility":221,"status":116,"city":222,"state":54,"zip":223,"country":103,"countryCode":104,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Clinique Rhéna","Strasbourg","67000",{"type":106,"coordinates":225},[226,227],7.74553,48.58392,{"lat":227,"lon":226},[230],{"name":231,"role":93,"phone":54,"phoneExt":54,"email":54},"Matjieu Schaaf, MD",{"facility":233,"status":100,"city":234,"state":54,"zip":235,"country":103,"countryCode":104,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Clinique Pasteur Service de cardiologie\u002Frythmologie","Toulouse","31076",{"type":106,"coordinates":237},[238,239],1.44367,43.60426,{"lat":239,"lon":238},[242],{"name":243,"role":93,"phone":54,"phoneExt":54,"email":54},"Jean-Paul Albenque, MD",{"facility":245,"status":116,"city":246,"state":54,"zip":247,"country":103,"countryCode":104,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Chu Nancy","Vandœuvre-lès-Nancy","54500",{"type":106,"coordinates":249},[250,251],6.17114,48.66115,{"lat":251,"lon":250},[254],{"name":255,"role":93,"phone":54,"phoneExt":54,"email":54},"Jean-Marc SELLAL, MD",{"type":257,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100459608",false,"NCT05264831","Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure","Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure in Patients With Persistent Atrial Fibrillation: a Randomized, Multicentric, and Comparative Study","PACIFIC","Inclusion criteria:\n\nCriteria to be validated for patients included before performing electric cardioversion:\n\n1\\) Persistent AF (continuous for at least 7 days without interruption according to information transmitted by the cardiologist and the patient), symptomatic and resistant to at leat one anti-arrhythmic drug treatment including amiodarone;\n\nCriteria to be validated for patients included after performing electric cardioversion :\n\n1. Patient treated by electric cardioversion for persistent AF, symptomatic and resistant to anti-arrhythmic treatment including amiodarone and whom ablative procedure is planned in the following 4-6 weeks after electric cardioversion\n\n   Criteria to be validated for all patients included:\n2. Life expectancy \\> 5 years;\n3. Female or male between 18 and 80 years of age at the electric cardioversion time\n4. Affiliation to a health insurance system;\n5. Patient informed of the study and having signed informed consent\n\n   Criteria to be validated prior to randomization on the day of ablation (these patients may be randomized):\n6. Patient with failed electric cardioversion i.e. in AF, confirmed by ECG.\n\nExclusion criteria:\n\nCriteria to be validated before or after performing electric cardioversion (the study cannot be proposed to patients corresponding to these criteria):\n\n1. Current hyperthyroidism;\n2. Pregnant or breastfeeding woman;\n3. Patient with a Body Mass Index (BMI) greater than 35;\n4. Patient with severe Chronic Obstructive Pulmonary Disease (COPD);\n5. Patient with hypertrophic heart disease;\n6. Patient with a mechanical or biological mitral valve;\n7. Contraindications to anticoagulants;\n8. Transient Ischemic Attack (TIA) \u002Fstroke less than 6 months old;\n9. Psychiatric illness affecting follow-up;\n10. Left Ventricular Ejection Fraction (LVEF) \\\u003C 40% ;\n11. Uncontrolled ischaemic heart disease (angina, myocardial ischaemia)\n12. Patients under legal protection\n13. Cardiac surgery on left atrium\n14. Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronic periodontitis, Crohn's disease, RCUH)\n15. Pulmonary embolism or phlebitis less than 6 months old\n16. Prior atrial fibrillation ablation\n17. Active cancer\n\n    Criteria to be validated before randomization, on the day of ablation (these patients cannot be randomized):\n18. Patient in sinus rhythm 4-6 weeks after electric cardioversion: these patients are included in the study registry.\n19. Patient with complete absence of sinus rhythm (less than 10 seconds) after 3 electric cardioversion attempts: these patients will discontinue from the study.","ALL","18 Years","80 Years",{"count":269,"type":270},450,"ESTIMATED","INTERVENTIONAL",[273],"NA","This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation.\n\nAll included patients will undergo an electric cardioversion, then:\n\n* Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients.\n* Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures:\n\n  * PVI procedure alone\n  * PVI procedure combined with substrate modulation",[276],"Persistent Atrial Fibrillation","2024-04-23",{"date":279,"type":280},"2024-04-24","ACTUAL",{"date":282,"type":280},"2023-02-20",{"date":284,"type":270},"2027-10-01",{"name":5,"class":6},13]