RECRUITING

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

Conditions

Bradycardia Heart Failure Ventricular Dysfunction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-03-18

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06641362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adults with bradycardia scheduled for pacemaker implant or heart failure patients indicated for cardiac resynchronization therapy (CRT) with one of the following: * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* Adults with bradycardia scheduled for pacemaker implant or heart failure patients indicated for cardiac resynchronization therapy (CRT) with one of the following:
* 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.

* 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.

Contacts and Locations

Study Contact

Randy LaBounty

CONTACT

9529136050

randy.labounty@vdimaging.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VDI Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-18

Study Completion Date2026-05

Study Record Updates

Study Start Date2025-03-18

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Bradycardia
Heart Failure
Ventricular Dysfunction