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NCT06641362Recruiting

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

VDI Technologies

Start Date

3/18/2025

Completion Date

5/1/2027

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adults with bradycardia or heart failure scheduled for first time pacemaker implant (including CRT/CSP) with one of the following: Bradycardia with ventricular synchrony and QRS duration \<= 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. Exclusion Criteria: * 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/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.

Interventions

DEVICE

Ultra High Frequency Electrocardiogram (UHF-ECG)

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Conditions

BradycardiaHeart FailureVentricular Dysfunction

Locations

Peak Heart and Vascular

Avondale, Arizona 85392

United States

Banner Medical Center

Mesa, Arizona 85202

United States

University of Chicago

Chicago, Illinois 60637

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Ohio State University

Columbus, Ohio 43210

United States

Baylor College of Medicine

Houston, Texas 77030

United States

University of Virginia

Charlottesville, Virginia 22908

United States

Fakultní nemocnice Brno

Brno, 625 00

Czechia

St. Anne's University Hospital

Brno, 65691

Czechia

Na Homolce Hospital

Prague, 150 30

Czechia

Fakultni Nemocnice Královské Vinohrady

Prague,

Czechia

Catherina Ziekenhuis

Eindhoven, 5623

Netherlands