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Vinohrady",{"type":37,"coordinates":180},[171,172],{"lat":172,"lon":171},[183],{"name":184,"role":49,"phone":10,"phoneExt":10,"email":10},"Petr Štros, MD",{"facility":186,"status":31,"city":187,"state":10,"zip":188,"country":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Catherina Ziekenhuis","Eindhoven","5623","Netherlands",{"type":37,"coordinates":191},[192,193],5.47778,51.44083,{"lat":193,"lon":192},[196],{"name":197,"role":49,"phone":10,"phoneExt":10,"email":10},"Nars Rademakers, MD",{"type":199,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":210,"type":211},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.",[215,216,217],"Bradycardia","Heart Failure","Ventricular Dysfunction","2026-05-04",{"date":220,"type":221},"2026-05-05","ACTUAL",{"date":223,"type":221},"2025-03-18",{"date":225,"type":211},"2027-05",{"name":5,"class":6},12]