[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545953":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":53,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Circa Scientific, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Arm","EXPERIMENTAL","Single arm of the study that receives treatment with the subject device.",[13],"Device: Rook Epicardial Access Kit",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Rook Epicardial Access Kit","Access the epicardial surface of the heart via a subxiphoid approach with the subject device to facilitate guidewire placement into the pericardium.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Petr Neuzil, MD","Nemocnice Na Homolce","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"David Director of Product Development","CONTACT","(303) 951-8767","201","david.willenbrink@circascientific.com",{"name":34,"role":29,"phone":30,"phoneExt":20,"email":35},"Alice Regulatory Affairs Manager, PhD","Alice.Ouyang@circascientific.com",[37],{"facility":38,"status":39,"city":40,"state":20,"zip":41,"country":42,"countryCode":20,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Na Homolce Hospital","RECRUITING","Prague","15030","Czechia",{"type":44,"coordinates":45},"Point",[46,47],14.42076,50.08804,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":20,"email":20},"Petr Neuzil, MD, PhD","+420257272211",{"type":54,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100545953","epicardial-access-study-with-rook-100545953",false,"NCT06388629","Epicardial Access Study With Rook","Epicardial Access Study With Rook (EASY-R)","EASY-R","Inclusion Criteria:\n\n1. Patient is clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space.\n2. Patient is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Subject is younger than 18 years of age\n2. Previous cardiac surgery\n3. Myocardial infarction within 4 weeks prior to procedure\n4. Class IV NYHA (New York Heart Association) heart failure symptoms\n5. Subject with an active systemic infection\n6. Known carotid artery stenosis greater than 80%\n7. Presence of thrombus in the left atrium\n8. Congenital absence of a pericardium\n9. Coagulopathy\n10. Hemodynamic Instability\n11. Acute conditions (i.e. electrolyte abnormality, acute ischemia, drug toxicity)\n12. Severe hepatic dysfunction or enlargement\n13. Subject has Body Mass Index \\> 40\n14. Life expectancy less than 6 months\n15. Subject is pregnant\n16. Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study\n17. Subject has known or suspected allergy to contrast media\n18. Subject is known to have pericardial fibrosis, pericardial adhesions, or prior failed epicardial access","ALL","18 Years",{"count":66,"type":67},40,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.\n\nParticipants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure.",[73],"Arrythmia",[75,76,77,78],"Electrophysiology","Pericardial Access","Epicardial Access","EP","2024-08-19",{"date":81,"type":82},"2024-08-21","ACTUAL",{"date":84,"type":82},"2023-12-17",{"date":86,"type":67},"2024-10-15",{"name":5,"class":6},1]