[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627601":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":11,"responsibleParty":31,"collaborators":11,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":11,"enrollmentInfo":45,"targetDuration":11,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":11},{"fullName":5,"class":6},"Asklepios proresearch","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Concomitant PVI plus LAAC","EXPERIMENTAL",null,[13,14],"Procedure: Interventional LAA Closure","Procedure: Pulmonary vein isolation",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"PROCEDURE","Interventional LAA Closure","LAA Closure to prevent stroke and bleeding",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Pulmonary vein isolation","Pulmonary vein isolation for atrial firbrillation treatment",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Christian-Hendrik Heeger, MD","CONTACT","0049-40-181881-8904","c.heeger@asklepios.com",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Prof. Christian-Hendrik Heeger","Prof. Dr.","100627601","concomitant-pfa-bsaed-pvi-plus-laac-100627601",false,"NCT07450755","Concomitant PFA Bsaed PVI Plus LAAC","Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study","COCONUT_2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing to participate\n* Atrial fibrillation and indication for PVI (ESC guideline 2024)\n* Indication for OAC therapy (CHA2DS2VA score \\>\u002F=2)\n\nExclusion Criteria:\n\n* Contraindications for PVI and \u002F or LAA closure\n* Pregnancy\n* Previous catheter ablation for AF","ALL","18 Years",{"count":46,"type":47},150,"ESTIMATED","INTERVENTIONAL",[50],"NA","A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific).\n\nFor procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.",[53,54,55],"Atrial Fibrillation (AF)","Bleeding","Stroke",[57,58,59],"Catheter ablation","Pulsed field ablation","LAAClosure","NOT_YET_RECRUITING","2026-03-11",{"date":63,"type":64},"2026-03-12","ACTUAL",{"date":66,"type":47},"2026-03-01",{"date":68,"type":47},"2027-12-31",{"name":5,"class":6}]