[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100289852":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":123,"collaborators":10,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":10,"enrollmentInfo":134,"targetDuration":10,"studyType":137,"phases":10,"briefSummary":138,"conditions":139,"keywords":10,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Boston Scientific Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All Subjects",null,"All subjects are included in this cohort and are treated with the Rhythmia Mapping System",[13],"Device: Rhythmia Mapping System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Rhythmia Mapping System","The Rhythmia Mapping System is a 3D electro-anatomical mapping system.",[9],[21],{"name":22,"affiliation":23,"role":24},"Thomas H McElderry, MD","University of Alabama at Birmingham","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Susan Hampson","CONTACT","5087285165","Susan.Hampson@bsci.com",[32,45,55,65,82,91,101,113],{"facility":23,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":10},"COMPLETED","Birmingham","Alabama","35233","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-86.80249,33.52066,{"lat":43,"lon":42},{"facility":46,"status":33,"city":47,"state":48,"zip":49,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":54,"contacts":10},"St. Lukes Idaho Cardiology Associates","Boise","Idaho","83712",{"type":40,"coordinates":51},[52,53],-116.20345,43.6135,{"lat":53,"lon":52},{"facility":56,"status":33,"city":57,"state":58,"zip":59,"country":37,"countryCode":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":10},"Lahey Clinic, Inc.","Burlington","Massachusetts","01805",{"type":40,"coordinates":61},[62,63],-71.19561,42.50482,{"lat":63,"lon":62},{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":37,"countryCode":38,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Cardiovascular Specialists of New England Research Foundation","RECRUITING","Londonderry","New Hampshire","03053",{"type":40,"coordinates":72},[73,74],-71.37395,42.86509,{"lat":74,"lon":73},[77,80],{"name":78,"role":28,"phone":10,"phoneExt":10,"email":79},"Jennifer Driscoll, RN, BSN","jennifer.driscoll@csofne.com",{"name":81,"role":24,"phone":10,"phoneExt":10,"email":10},"Jamie Kim, MD",{"facility":83,"status":33,"city":84,"state":69,"zip":85,"country":37,"countryCode":38,"cosmosGeoPoint":86,"geoPoint":90,"contacts":10},"Catholic Medical Center","Manchester","03102",{"type":40,"coordinates":87},[88,89],-71.45479,42.99564,{"lat":89,"lon":88},{"facility":92,"status":33,"city":93,"state":94,"zip":95,"country":37,"countryCode":38,"cosmosGeoPoint":96,"geoPoint":100,"contacts":10},"Valley Hospital","Ridgewood","New Jersey","07450-2736",{"type":40,"coordinates":97},[98,99],-74.11653,40.97926,{"lat":99,"lon":98},{"facility":102,"status":33,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":10},"Fondazione Centro San Raffaele","Milan","MI","20132","Italy","IT",{"type":40,"coordinates":109},[110,111],9.18951,45.46427,{"lat":111,"lon":110},{"facility":114,"status":33,"city":115,"state":10,"zip":116,"country":115,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":122,"contacts":10},"Centre Hospitalier Princesse Grace","Monaco","98000","MC",{"type":40,"coordinates":119},[120,121],7.42145,43.73718,{"lat":121,"lon":120},{"type":124,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100289852","rhythmia-mapping-and-signal-acquisition-for-data-analysis-rhapsody-100289852",false,"NCT03053141","RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)","RHAPSODY","Inclusion Criteria:\n\n1. Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law\n2. Scheduled for standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System.\n\nExclusion Criteria:\n\n1. Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia\n2. Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy, etc.)\n3. Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route\n4. Active systemic infection or sepsis\n5. Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator.\n6. Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction\n7. Women who are pregnant or lactating\n8. Cardiac surgery within the past 90 days\n9. Acute myocardial infarction within 3 months\n10. Stable\u002Funstable angina or ongoing myocardial ischemia\n11. Subjects with an active heart failure decompensation\n12. Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes\n13. Congenital heart disease with or without corrective surgery that would complicate a mapping procedure\n14. Subjects having untreatable allergy to contrast media\n15. Vascular pathology or tortuosity precluding standard vascular access techniques\n16. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.","ALL","18 Years",{"count":135,"type":136},100,"ESTIMATED","OBSERVATIONAL","The objective of the RHAPSODY study is to evaluate the performance of new software features in subjects undergoing standard of care catheter-based endocardial mapping for atrial or ventricular tachyarrhythmias using a commercial Rhythmia Mapping System. Results from this study will be used to guide development and refinement of new software features that may be implemented in future commercial software releases.",[140],"Cardiac Arrythmias","2026-06-29",{"date":143,"type":144},"2026-06-30","ACTUAL",{"date":146,"type":144},"2016-05",{"date":148,"type":136},"2027-12",{"name":5,"class":6},8]