RecruitingNCT06641362

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


Sponsor

VDI Technologies

Enrollment

360 participants

Start Date

Mar 18, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new type of electrocardiogram (ECG) technology called Ultra-High Frequency ECG (UHF-ECG) to see if it can better detect abnormal electrical patterns in the heart, particularly for people who need a pacemaker or a device to help the heart beat in sync. **You may be eligible if...** - You are an adult scheduled to receive a pacemaker for a slow heart rate, OR - You have heart failure and are scheduled to receive a cardiac resynchronization therapy (CRT) device - Your heart condition fits specific criteria regarding the electrical pattern (QRS duration) on a standard ECG - You are willing to comply with study requirements **You may NOT be eligible if...** - You have a complete third-degree heart block without a reliable heart rhythm - You already have a pacemaker or defibrillator - You have a skin condition or allergy that makes it hard to attach ECG pads - You are pregnant - You are enrolled in a conflicting device study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUltra 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

View Full Details on ClinicalTrials.gov

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NCT06641362


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