[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VDI Technologies\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100565375","ultra-high-frequency---electrocardiogram-uhf-ecg-for-the-diagnosis-of-ventricular-electrical-dyssynchrony-ved-100565375",false,"NCT06641362","Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)","Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study","SYNC","Inclusion Criteria:\n\n* Adults with bradycardia or heart failure scheduled for first time pacemaker implant (including CRT\u002FCSP) with one of the following: Bradycardia with ventricular synchrony and QRS duration \\\u003C= 110 ms, Bradycardia with LBBB, Bradycardia with RBBB, Bradycardia with other IVCD necessitating intervention, or Heart failure with LBBB\n* Understands the nature of the study and is willing to comply with all study requirements.\n* Provides written informed consent.\n* A negative pregnancy test prior to the procedure for participants of child-bearing potential.\n\nExclusion Criteria:\n\n* Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS.\n* Subjects with a previous or current pacemaker or defibrillator implant.\n* Anatomical or other conditions that may make a 12-lead ECG difficult to obtain, such as an allergy to components of the ECG pads, burns, open wounds, etc.\n* Currently enrolled in another investigational device or drug trial that has not completed the active treatment phase and\u002For would conflict with this study.\n* Other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with study requirements or impact the scientific integrity of the study.","ALL","18 Years",{"count":20,"type":21},360,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to demonstrate the safety and effectiveness of the VDI UHF-ECG System in the diagnosis of ventricular dyssynchrony when compared to the 12-lead ECG in patients with bradycardia and heart failure indicated for pacemaker implantation.",[25,26,27],"Bradycardia","Heart Failure","Ventricular Dysfunction","RECRUITING","2026-05-04",{"date":31,"type":32},"2026-05-05","ACTUAL",{"date":34,"type":32},"2025-03-18",{"date":36,"type":21},"2027-05",{"name":38,"class":39},"VDI Technologies","INDUSTRY",12,""]