[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643452":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":27,"armGroups":23,"interventions":28,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":144,"collaborators":146,"id":150,"slug":23,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":23,"eligibilityCriteria":154,"healthyVolunteers":151,"sex":155,"minAge":156,"maxAge":23,"enrollmentInfo":157,"targetDuration":23,"studyType":160,"phases":23,"briefSummary":161,"conditions":162,"keywords":23,"overallStatus":46,"whyStopped":23,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Northwell Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of atrial fibrillation","Incidence of atrial fibrillation in patients implanted with a single chamber (Aveir AR, Abbott) leadless pacemaker and a loop recorder.","24 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Composite incidence of a newly prolonged PR interval","Composite incidence of a newly prolonged PR interval \\>\u002F= 300ms or a need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years",{"measure":18,"description":19,"timeFrame":12},"Need for system upgrade from a single chamber to dual chamber","Need for system upgrade from a single chamber (Aveir AR, Abbott) leadless pacemaker to a dual chamber leadless pacemaker (Aveir DR, Abbott) at two-years.",{"measure":21,"description":22,"timeFrame":12},"Battery Longevity","Remaining battery longevity of the single chamber leadless atrial pacemaker (Aveir, AR) compared with remaining battery longevity of subjects in the Aveir DR i2i study implanted with a dual chamber leadless pacemaker with comparable percentages of atrial pacing without ventricular pacing.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","1. 50 patients who receive an Aveir AR device as standard of care\n2. Patients willing to receive an Assert-IQ loop recorder for research purposes\n3. All sexes\n4. Age \\> 18 years old\n5. Able to provide written informed consent",[29],{"type":30,"name":31,"description":32,"armGroupLabels":23,"otherNames":23},"DEVICE","Implantable Loop Recorder","Implantation of a loop recorder in subjects with sick sinus syndrome and normal atrioventricular conduction who are receiving an atrial leadless pacemaker as standard of care.",[34],{"name":35,"affiliation":5,"role":36},"James Gabriels, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Salome Elia Reddy","CONTACT","516-881-7067","seliareddy@northwell.edu",[44,65,80,94,109,123],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"South Shore University Hospital","RECRUITING","Bay Shore","New York","11706","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-73.24539,40.7251,{"lat":56,"lon":55},[59,62],{"name":60,"role":40,"phone":23,"phoneExt":23,"email":61},"Rachel Gentles","rgentles1@northwell.edu",{"name":63,"role":64,"phone":23,"phoneExt":23,"email":23},"Jason Chinitz, MD","SUB_INVESTIGATOR",{"facility":66,"status":46,"city":67,"state":48,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Huntington Hospital","Huntington","11743",{"type":53,"coordinates":70},[71,72],-73.42568,40.86815,{"lat":72,"lon":71},[75,78],{"name":76,"role":40,"phone":23,"phoneExt":23,"email":77},"Jane Hubert","jhubert@northwell.edu",{"name":79,"role":64,"phone":23,"phoneExt":23,"email":23},"Paul Maccaro, MD",{"facility":81,"status":46,"city":82,"state":48,"zip":83,"country":50,"countryCode":51,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"North Shore University Hospital","Manhasset","11030",{"type":53,"coordinates":85},[86,87],-73.69957,40.79788,{"lat":87,"lon":86},[90,91,92],{"name":39,"role":40,"phone":23,"phoneExt":23,"email":42},{"name":35,"role":36,"phone":23,"phoneExt":23,"email":23},{"name":93,"role":64,"phone":23,"phoneExt":23,"email":23},"Laurence Epstein, MD",{"facility":95,"status":46,"city":96,"state":48,"zip":97,"country":50,"countryCode":51,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Long Island Jewish Medical Center","New Hyde Park","11040",{"type":53,"coordinates":99},[100,101],-73.68791,40.7351,{"lat":101,"lon":100},[104,105,107],{"name":39,"role":40,"phone":23,"phoneExt":23,"email":42},{"name":106,"role":64,"phone":23,"phoneExt":23,"email":23},"Bruce Goldner, MD",{"name":108,"role":64,"phone":23,"phoneExt":23,"email":23},"Moussa Saleh, MD",{"facility":110,"status":46,"city":48,"state":48,"zip":111,"country":50,"countryCode":51,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Lenox Hill Hospital","10075",{"type":53,"coordinates":113},[114,115],-74.00597,40.71427,{"lat":115,"lon":114},[118,121],{"name":119,"role":40,"phone":23,"phoneExt":23,"email":120},"Kristie Coleman","kcoleman1@northwell.edu",{"name":122,"role":64,"phone":23,"phoneExt":23,"email":23},"Nicholas Skipitaris, MD",{"facility":124,"status":46,"city":125,"state":48,"zip":126,"country":50,"countryCode":51,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Staten Island University Hospital","Staten Island","10305",{"type":53,"coordinates":128},[129,130],-74.13986,40.56233,{"lat":130,"lon":129},[133,136,138,140,142],{"name":134,"role":40,"phone":23,"phoneExt":23,"email":135},"Alexandra Pantea","apantea@northwell.edu",{"name":137,"role":64,"phone":23,"phoneExt":23,"email":23},"Marcin Kowalski, MD",{"name":139,"role":64,"phone":23,"phoneExt":23,"email":23},"Valay Parikh, MD",{"name":141,"role":64,"phone":23,"phoneExt":23,"email":23},"Samer Saouma, MD",{"name":143,"role":64,"phone":23,"phoneExt":23,"email":23},"Rina Shah, MD",{"type":145,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[147],{"name":148,"class":149},"Abbott","INDUSTRY","100643452",false,"NCT07638995","Single Chamber Atrial Leadless Pacing for Isolated Sinus Node Dysfunction","Inclusion Criteria:\n\n1. Symptomatic sinus bradycardia\n2. Sino-atrial exit block\n3. Symptomatic sinus arrest with sinus pauses \\> 2 sec during waking hours\n4. Symptomatic sinus bradycardia \\\u003C 40 bpm for \\> 1 min during waking hours\n5. PR interval ≤ 0.22 sec if aged \\\u003C 70 years or PR interval ≤ 0.26 sec if aged ≥ 70 years\n6. QRS width ≤ 0.12 sec\n7. No prior PM implantation\n8. Patients willing to receive an Assert-IQ loop recorder for research purposes\n\nExclusion Criteria:\n\n1. Atrioventricular block\n2. Bundle branch block\n3. History of atrial fibrillation\n4. Carotid sinus hypersensitivity\n5. Planned cardiac surgery\n6. Estimated life expectancy \\\u003C 1 year\n7. Presence of an existing ventricular pacemaker or implantable cardioverter defibrillator\n8. Known acute deep vein thrombosis of either lower extremity\n9. Unable to read or write\n10. Patient with Limited English Proficiency (LEP)\n11. Cognitively impaired individuals\n12. Pregnant","ALL","18 Years",{"count":158,"type":159},50,"ESTIMATED","OBSERVATIONAL","The study aims to evaluate the following: 1) the incidence of new onset atrial fibrillation in patients with an atrial leadless pacemaker, 2) the need for upgrade from a standalone atrial leadless pacemaker to a dual chamber leadless pacemaker system, and 3) to compare the battery longevity of the Aveir AR at two years with the battery longevity of subjects implanted with dual chamber leadless pacemakers in the Aveir DR i2i study.",[163],"Atrial Fibrillation","2026-06-05",{"date":166,"type":167},"2026-06-10","ACTUAL",{"date":169,"type":167},"2026-05-18",{"date":171,"type":159},"2029-12-31",{"name":5,"class":6},6]