[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488678":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":26,"locations":34,"responsibleParty":70,"collaborators":19,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":19,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":19,"enrollmentInfo":82,"targetDuration":19,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Northwell Health","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR","Patients free of documented arrhythmia initiating treatment with a BTK inhibitor who consent to monitoring using the Medtronic LINQ-2 implanted cardiac monitoring device (ILR) prior to initiating BTK inhibitor therapy.",[12],"Device: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)","Patients initiating BTK inhibitors will be offered the option of monitoring using the Medtronic Insertable Cardiac Monitor (ILR). The device will be implanted by a certified and credentialed electrophysiologist to enable monitoring to begin at least 24 hours prior to the first administration of the BTK inhibitor. Monitoring data will be collected prospectively until the patient withdraws consent, the device is removed, or up to 60 months",[9],null,[21,24],{"name":22,"affiliation":5,"role":23},"Robert S Copeland-Halperin, MD","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":5,"role":23},"Haisam Ismail, MD",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":19,"email":31},"Efstathia Mihelis","CONTACT","212-434-6614","emihelis@northwell.edu",{"name":22,"role":29,"phone":33,"phoneExt":19,"email":19},"718-470-7330",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Northwell (Northshore University\u002FLong Island Jewish Hospitals)","RECRUITING","New Hyde Park","New York","11040","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-73.68791,40.7351,{"lat":47,"lon":46},[50,52,54,57,59,61,63,65,66,68],{"name":51,"role":29,"phone":30,"phoneExt":19,"email":31},"Efstathia A Mihelis",{"name":53,"role":29,"phone":33,"phoneExt":19,"email":19},"Robert S. Copeland-Halperin, MD",{"name":55,"role":56,"phone":19,"phoneExt":19,"email":19},"Michelle Jaeger, NP","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":19,"phoneExt":19,"email":19},"Nandanee Karan",{"name":60,"role":56,"phone":19,"phoneExt":19,"email":19},"Joanna Rhodes, MD",{"name":62,"role":56,"phone":19,"phoneExt":19,"email":19},"Nicholas Beccarino, MD",{"name":64,"role":56,"phone":19,"phoneExt":19,"email":19},"Jason Ng, MD",{"name":25,"role":56,"phone":19,"phoneExt":19,"email":19},{"name":67,"role":23,"phone":19,"phoneExt":19,"email":19},"Robert Copeland-Halperin, MD",{"name":69,"role":23,"phone":19,"phoneExt":19,"email":19},"Laurence Epstein, MD",{"type":23,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Robert Copeland-Halperin, MD FACC","Assistant Professor of Cardiology","100488678","implanted-loop-recorders-for-detection-and-management-of-arrhythmia-with-bruton-tyrosine-kinase-inhibitors-100488678",false,"NCT05643235","Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors","Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors","Inclusion Criteria:\n\n* \\>18yo\n* Willing to sign and date consent form,\n* Willing to be remotely monitored\n* Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)\n* Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor\n\nExclusion Criteria:\n\n* Documented AF\u002FVA in past 12 months\n* Cerebral Vascular Accident (CVA) or Transient Ischemic Attack (TIA) in past year\n* Has current implanted pulse generator, defibrillator, pacemaker, or resynchronization device\n* heart surgery within past 90 days\n* Myocardial Infarction within past 90 days\n* Patient is taking an anti-arrhythmic or anticoagulant\n* has concomitant condition that precludes safe participation in study (substance abuse, etc)\n* Enrollment in separate study that could confound results of this study","ALL","18 Years",{"count":83,"type":84},50,"ESTIMATED","INTERVENTIONAL",[87],"NA","This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.",[90,91,92,93,94],"Atrial Fibrillation","Supraventricular Arrhythmia","Ventricular Arrhythmias and Cardiac Arrest","Chronic Lymphocytic Leukemia","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma",[96,97,98,99,100,101,102,103,104,105,106,107],"Bruton tyrosine kinase (BTK)","Chronic Lymphocytic Leukemia (CLL)","Mantle Cell Lymphoma","Waldenstrom's macroglobulinemia","atrial fibrillation (AF)","ventricular arrhythmia (VA)","sudden cardiac death","ibrutinib","acalabrutinib","zanubrutinib","pirtobrutinib","Implanted Loop Recorder\u002FImplanted Cardiac Monitor (ILR)","2025-09-12",{"date":110,"type":111},"2025-09-18","ACTUAL",{"date":113,"type":111},"2023-01-01",{"date":115,"type":84},"2030-12-01",{"name":5,"class":6},1]