[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522139":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":103,"collaborators":18,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":18,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":18,"enrollmentInfo":114,"targetDuration":18,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":18,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Kansas City Heart Rhythm Research Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LockeT","EXPERIMENTAL","These are the patients assigned for LockeT device arm to close the access site wound.",[13],"Device: Vascular closure with LockeT device",{"label":15,"type":16,"description":17,"interventionNames":18},"Manual compression","NO_INTERVENTION","These are the patients assigned for Manual Compression arm to close the access site wound.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Vascular closure with LockeT device","For subjects that are assigned to the LockeT device arm, the healthcare professional will place the LockeT with suture above the wound to achieve compression instead of manually holding pressure on the sutures. After hemostasis is achieved and prior to ambulation the LockeT will be removed followed by suture removal.",[9],[26],{"name":27,"affiliation":28,"role":29},"Dhanunjaya Lakkireddy, MD","Kansas City Heart Rhythm Institute","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Donita Atkins","CONTACT","816-651-1969","Datkins@kchrf.com",[37,54,62,75,82,95],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Kansas City Heart Rhythm Institute - Roe Clinic","RECRUITING","Overland Park","Kansas","66211","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-94.67079,38.98223,{"lat":49,"lon":48},[52,53],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"facility":55,"status":39,"city":40,"state":41,"zip":56,"country":43,"countryCode":44,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Overland Park Regional Medical Center","66215",{"type":46,"coordinates":58},[48,49],{"lat":49,"lon":48},[61],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"facility":63,"status":39,"city":64,"state":65,"zip":66,"country":43,"countryCode":44,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Centerpoint Medical Center Clinic","Independence","Missouri","64057",{"type":46,"coordinates":68},[69,70],-94.41551,39.09112,{"lat":70,"lon":69},[73],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":74},"datkins@kchrf.com",{"facility":76,"status":39,"city":64,"state":65,"zip":66,"country":43,"countryCode":44,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Centerpoint Medical Center",{"type":46,"coordinates":78},[69,70],{"lat":70,"lon":69},[81],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":74},{"facility":83,"status":39,"city":84,"state":65,"zip":85,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Research Medical Center Clinic","Kansas City","64032",{"type":46,"coordinates":87},[88,89],-94.57857,39.09973,{"lat":89,"lon":88},[92,93],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":94,"role":29,"phone":18,"phoneExt":18,"email":18},"Naga Venkata K. Pothineni, MD",{"facility":96,"status":39,"city":84,"state":65,"zip":85,"country":43,"countryCode":44,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Research Medical Center",{"type":46,"coordinates":98},[88,89],{"lat":89,"lon":88},[101,102],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":94,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":104,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100522139","vascular-closure-with-a-device-compared-to-manual-compression-after-atrial-fibrillation-ablation-the-locket-ii-study-100522139",false,"NCT06078735","Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study","Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study","Inclusion Criteria:\n\n* Must be at least 18 years of age\n* Be able to provide consent\n* Presenting for planned procedures that require percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, and where the physician utilizes a LockeT device or MC to close the wound.\n\nExclusion Criteria:\n\n* Under the age of 18\n* Unable to or unwilling to provide consent\n* Cannot comply with study requirements\n* Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and\u002For ventricle\n* Subjects whose physician does not use LockeT or MC to close the venous puncture.\n* Patient is currently pregnant, as evidenced by positive urine Beta-HCG. (Urine Beta Human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).\n* If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.","ALL","18 Years",{"count":115,"type":116},110,"ESTIMATED","INTERVENTIONAL",[119],"NA","The LockeT II study is a single center, prospective randomized study. It is intended to study the effectiveness of using LockeT device to gain hemostasis after venous procedures as compared to Manual Compression (MC). Approximately 110 patients will be enrolled.",[122,123],"Atrial Fibrillation","Hemostasis","2024-10-25",{"date":126,"type":127},"2024-10-29","ACTUAL",{"date":129,"type":127},"2023-10-02",{"date":131,"type":116},"2024-12",{"name":5,"class":6},6]