Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
NCT ID: NCT06641362
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
360 participants
OBSERVATIONAL
2025-03-18
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Treatment Group
Participant controlled with standard ECG measurement and VDI UHF-ECG measurement both taken sequentially.
Ultra High Frequency Electrocardiogram (UHF-ECG)
Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Interventions
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Ultra High Frequency Electrocardiogram (UHF-ECG)
Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bradycardia with ventricular synchrony and QRS duration \< 110 ms in men or \< 100 ms in women or;
* Bradycardia with left bundle branch block and QRS duration \> 140 ms in men or \> 130 ms in women or;
* Bradycardia with right bundle branch block and QRS duration \> 130 ms in men or \> 120 ms in women or;
* Heart failure with left bundle branch block and QRS duration \> 140 ms in men or \>130 ms in women.
* 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.
Exclusion Criteria
* 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/or 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.
18 Years
ALL
No
Sponsors
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VDI Technologies
INDUSTRY
Responsible Party
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Locations
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Peak Heart and Vascular
Avondale, Arizona, United States
Banner Medical Center
Mesa, Arizona, United States
University of Chicago
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
St. Anne's University Hospital
Brno, , Czechia
Catherina Ziekenhuis
Eindhoven, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Dalise Dai
Role: primary
Adrianne Miller
Role: primary
Stephen Harold
Role: primary
Cathy Roy
Role: primary
Andrej Nagy, MD
Role: primary
References
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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/CIRCEP.117.005719. Epub 2018 Apr 26.
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/s41598-021-90963-4.
Related Links
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sponsor website
Other Identifiers
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CLIN001
Identifier Type: -
Identifier Source: org_study_id
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