RECRUITING

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

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.

Conditions

BradycardiaHeart FailureVentricular Dysfunction
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Related Conditions:

BradycardiaHeart FailureVentricular Dysfunction

Study Overview

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Study Details

Study overview

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.

Pivotal Clinical Study of VDI's Ultra-High Frequency Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED): THE SYNC Study

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

Condition
Bradycardia
Intervention / Treatment

-

Contacts and Locations

Avondale

Peak Heart and Vascular, Avondale, Arizona, United States, 85392

Mesa

Banner Medical Center, Mesa, Arizona, United States, 85202

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VDI Technologies,

Study Record Dates

2026-05