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RECRUITING
NCT06641362

Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)

Sponsor: VDI Technologies

View on ClinicalTrials.gov

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

DEVICE

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