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Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Sponsor: VDI Technologies
Summary
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.
Official title: Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
360
Start Date
2025-03-18
Completion Date
2026-05
Last Updated
2025-09-04
Healthy Volunteers
No
Interventions
Ultra High Frequency Electrocardiogram (UHF-ECG)
Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Locations (9)
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