[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567549":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":30,"armGroups":31,"interventions":37,"overallOfficials":26,"centralContacts":43,"locations":26,"responsibleParty":52,"collaborators":54,"id":58,"slug":26,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":26,"maxAge":26,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":26,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"Heart Rhythm Clinical and Research Solutions, LLC","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Long term effectiveness","defined as freedom from recurrence of AF\u002FAT\u002FAFL \\>30 sec at 12-month follow-up","12-month",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Acute success","ability to obtain pulmonary vein isolation during the ablation using TactiFlex catheter only","at time of procedure",{"measure":19,"description":20,"timeFrame":21},"Acute safety","rate of acute safety events defined as procedure or device related complications that occur within 7 days of the procedure and incidence per-procedural complications that occur greater than 7 days but less than 30 days post ablation","30 days",{"measure":23,"description":24,"timeFrame":25},"Long term safety","Rate of long-term safety events defined as procedure or device related complications that occur greater than 30 days post ablation.","12 months",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","Participants with atrial fibrillation undergoing ablation at selected sites who meet eligibility. Site in US, Canda, and OUS",[32],{"label":33,"type":26,"description":34,"interventionNames":35},"Patients undergoing AF Ablation using TactiFlex catheter","patients undergoing de novo or redo AF ablation procedures using TactiFlex ablation catheter following patients up to 6 to 12 months follow up.",[36],"Device: Ablation",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":26},"DEVICE","Ablation","Ablation procedure for Atrial Fibrillation",[33],[44,49],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Kim Harbin","CONTACT","256-591-0727","kharbin@hrcrs.com",{"name":50,"role":46,"phone":26,"phoneExt":26,"email":51},"Courtney Muenchow","cmuenchow@hrcrs.com",{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[55],{"name":56,"class":57},"Abbott","INDUSTRY","100567549",false,"NCT06669637","Amplify EP Registry","AMP","Inclusion Criteria:\n\n* Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation.\n* Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott.\n* De Novo or redo AF catheter ablation procedures.\n* Able and willing to participate in baseline and all follow up evaluations.\n* 18 years of age or older.\n\nExclusion Criteria:\n\n* Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure.\n* In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.","ALL",{"count":66,"type":67},1100,"ESTIMATED","12 Months","OBSERVATIONAL","An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation",[72],"Atrial Fibrillation",[40,74],"Radiofrequency","NOT_YET_RECRUITING","2024-10-30",{"date":78,"type":79},"2024-11-01","ACTUAL",{"date":81,"type":67},"2024-11-22",{"date":83,"type":67},"2026-12",{"name":5,"class":6}]