[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06641362":3,"trial-entities:NCT06641362":227,"trial-summary:NCT06641362":230},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":61,"locations":64,"central_contacts":209,"overall_officials":214,"references":215,"see_also_links":223},"NCT06641362","CLIN001","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","RECRUITING","2027-05","2026-05","2026-05-05","2025-03-18","VDI Technologies","INDUSTRY",false,"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.",null,[19,20,21],"Bradycardia","Heart Failure","Ventricular Dysfunction",[],"OBSERVATIONAL",[],{"count":26,"type":27},360,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DEVICE","Ultra High Frequency Electrocardiogram (UHF-ECG)","Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and\u002For heart failure.",[34],"Treatment Group",[36],"Standard 12 lead Electrocardiogram (ECG)",[38],{"measure":39,"description":40,"timeFrame":41},"Predictive agreement between UHF-ECG and standard ECG","Positive and negative predictive agreement between standard 12-lead ECG and UHF-ECG in discrimination of ventricular synchrony versus dyssynchrony with one recording per participant taken pre-procedure as evaluated by the core laboratory.","Pre-procedure",[43],{"measure":44,"description":45,"timeFrame":41},"Predictive agreement in dyssynchrony between UHF-ECG and standard ECG","Predictive agreement of ventricular dyssynchrony and sidedness on the pre-procedure 12-lead ECG compared of UHF-ECG in participants with identified ventricular dyssynchrony.","ALL","18 Years",{"inclusion":49,"exclusion":54,"raw_text":60},[50,51,52,53],"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","Understands the nature of the study and is willing to comply with all study requirements.","Provides written informed consent.","A negative pregnancy test prior to the procedure for participants of child-bearing potential.",[55,56,57,58,59],"Complete AV block (3rd-degree AV block) without a stable escape rhythm or other circumstances where there is no measurable QRS.","Subjects with a previous or current pacemaker or defibrillator implant.","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.","Currently enrolled in another investigational device or drug trial that has not completed the active treatment phase and\u002For would conflict with this study.","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.","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.",[62,63],"ADULT","OLDER_ADULT",[65,83,95,110,125,138,151,164,175,182,192,198],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":80},"Peak Heart and Vascular","Avondale","Arizona","85392","United States",[72,77],{"name":73,"role":74,"phone":75,"email":76},"Tasha Marriott","CONTACT","602-730-9500","tasha.marriott@axsendoclinical.com",{"name":78,"role":79},"Andy Tran, MD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},33.4356,-112.3496,{"facility":84,"status":8,"city":85,"state":68,"zip":86,"country":70,"contacts":87,"geoPoint":92},"Banner Medical Center","Mesa","85202",[88,90],{"name":89,"role":74},"Dalise Dai",{"name":91,"role":79},"Roderick Tung, MD",{"lat":93,"lon":94},33.42227,-111.82264,{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":70,"contacts":100,"geoPoint":107},"University of Chicago","Chicago","Illinois","60637",[101,105],{"name":102,"role":74,"phone":103,"email":104},"Kie Ng","773-702-1015","kie@bsd.uchicago.edu",{"name":106,"role":79},"Gaurav Upadhyay, MD",{"lat":108,"lon":109},41.85003,-87.65005,{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":70,"contacts":115,"geoPoint":122},"Mayo Clinic","Rochester","Minnesota","55905",[116,120],{"name":117,"role":74,"phone":118,"email":119},"Brent Quam","507-422-3235","Quam.Brent@mayo.edu",{"name":121,"role":79},"Yong-Mei Cha, MD",{"lat":123,"lon":124},44.02163,-92.4699,{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":70,"contacts":130,"geoPoint":135},"Ohio State University","Columbus","Ohio","43210",[131,133],{"name":132,"role":74},"Adrianne Miller",{"name":134,"role":79},"Shrinivas Hebsur, MD",{"lat":136,"lon":137},39.96118,-82.99879,{"facility":139,"status":8,"city":140,"state":141,"zip":142,"country":70,"contacts":143,"geoPoint":148},"Baylor College of Medicine","Houston","Texas","77030",[144,146],{"name":145,"role":74},"Stephen Harold",{"name":147,"role":79},"Michael Chelu, MD",{"lat":149,"lon":150},29.76328,-95.36327,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":70,"contacts":156,"geoPoint":161},"University of Virginia","Charlottesville","Virginia","22908",[157,159],{"name":158,"role":74},"Cathy Roy",{"name":160,"role":79},"Kenneth Bilchick, MD",{"lat":162,"lon":163},38.02931,-78.47668,{"facility":165,"status":8,"city":166,"zip":167,"country":168,"contacts":169,"geoPoint":172},"Fakultní nemocnice Brno","Brno","625 00","Czechia",[170],{"name":171,"role":79},"Milan Sepši, MD",{"lat":173,"lon":174},49.19522,16.60796,{"facility":176,"status":8,"city":166,"zip":177,"country":168,"contacts":178,"geoPoint":181},"St. Anne's University Hospital","65691",[179],{"name":180,"role":74},"Andrej Nagy, MD",{"lat":173,"lon":174},{"facility":183,"status":8,"city":184,"zip":185,"country":168,"contacts":186,"geoPoint":189},"Na Homolce Hospital","Prague","150 30",[187],{"name":188,"role":79},"Milan Chovanec, MD",{"lat":190,"lon":191},50.08804,14.42076,{"facility":193,"status":8,"city":184,"country":168,"contacts":194,"geoPoint":197},"Fakultni Nemocnice Královské Vinohrady",[195],{"name":196,"role":79},"Petr Štros, MD",{"lat":190,"lon":191},{"facility":199,"status":8,"city":200,"zip":201,"country":202,"contacts":203,"geoPoint":206},"Catherina Ziekenhuis","Eindhoven","5623","Netherlands",[204],{"name":205,"role":79},"Nars Rademakers, MD",{"lat":207,"lon":208},51.44083,5.47778,[210],{"name":211,"role":74,"phone":212,"email":213},"Randy LaBounty","9529136050","randy.labounty@vdimaging.com",[],[216,220],{"pmid":217,"type":218,"citation":219},"29700054","BACKGROUND","Plesinger F, Jurak P, Halamek J, Nejedly P, Leinveber P, Viscor I, Vondra V, McNitt S, Polonsky B, Moss AJ, Zareba W, Couderc JP. Ventricular Electrical Delay Measured From Body Surface ECGs Is Associated With Cardiac Resynchronization Therapy Response in Left Bundle Branch Block Patients From the MADIT-CRT Trial (Multicenter Automatic Defibrillator Implantation-Cardiac Resynchronization Therapy). Circ Arrhythm Electrophysiol. 2018 May;11(5):e005719. doi: 10.1161\u002FCIRCEP.117.005719. Epub 2018 Apr 26.",{"pmid":221,"type":218,"citation":222},"34075135","Jurak P, Bear LR, Nguyen UC, Viscor I, Andrla P, Plesinger F, Halamek J, Vondra V, Abell E, Cluitmans MJM, Dubois R, Curila K, Leinveber P, Prinzen FW. 3-Dimensional ventricular electrical activation pattern assessed from a novel high-frequency electrocardiographic imaging technique: principles and clinical importance. Sci Rep. 2021 Jun 1;11(1):11469. doi: 10.1038\u002Fs41598-021-90963-4.",[224],{"label":225,"url":226},"sponsor website","http:\u002F\u002Fwww.vdimaging.com",{"nct_id":4,"conditions":228,"biomarkers":229},[19,20,21],[],{"nct_id":4,"found":231,"summary":232,"prompt_version":242},true,{"design":233,"status":234,"heading":235,"summary":236,"follow_up":237,"word_count":238,"commitments":239,"compensation":240,"drugs_mentioned":241},"This is an observational study planning to enroll 360 participants. It compares the UHF-ECG device to a standard ECG.","completed","UHF-ECG for Diagnosing Ventricular Electrical Dyssynchrony","This study is looking at a new way to diagnose a heart condition called ventricular electrical dyssynchrony (VED) using a special heart test called Ultra-High Frequency Electrocardiogram (UHF-ECG). Researchers want to see how well the UHF-ECG compares to the standard 12-lead ECG in patients who have bradycardia (slow heart rate) or heart failure and are scheduled to get a pacemaker. You might be able to join if you are an adult with bradycardia or heart failure and are scheduled for your first pacemaker implant. The study will be considered successful if the UHF-ECG results match the standard ECG results. The current recruitment status is unclear.","The primary endpoint is measured pre-procedure, so long-term follow-up is not specified.",105,"You would undergo an Ultra High Frequency Electrocardiogram (UHF-ECG) before your pacemaker procedure.","Not stated in the trial record.",[],"v2"]