Recruiting

VDI UHF-ECG System

Sponsor:

VDI Technologies

Code:

NCT06641362

Conditions

Bradycardia

Heart Failure

Ventricular Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultra High Frequency Electrocardiogram (UHF-ECG)

Study Details

Brief 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.

Conditions

Bradycardia

Heart Failure

Ventricular Dysfunction

Study ID

NCT06641362

Start date

Mar 18, 2025

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

Participant controlled with standard ECG measurement and VDI UHF-ECG measurement both taken sequentially.

Interventions

Ultra High Frequency Electrocardiogram (UHF-ECG)

Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.

Primary outcome measure

  • Predictive agreement between UHF-ECG and standard ECG [ Time Frame: Pre-procedure ]

Central Contacts and Locations

Central contacts

Randy LaBounty

9529136050randy.labounty@vdimaging.com

Locations

Peak Heart and Vascular

Recruiting

Avondale, Arizona, United States, 85392

Contacts

Tasha Marriott

602-730-9500tasha.marriott@axsendoclinical.com

Principal Investigator:

Andy Tran, MD

Banner Medical Center

Recruiting

Mesa, Arizona, United States, 85202

Principal Investigator:

Roderick Tung, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Kie Ng

773-702-1015kie@bsd.uchicago.edu

Principal Investigator:

Gaurav Upadhyay, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Brent Quam

507-422-3235Quam.Brent@mayo.edu

Principal Investigator:

Yong-Mei Cha, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Shrinivas Hebsur, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Michael Chelu, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Kenneth Bilchick, MD

More Information

Sponsor

VDI Technologies

Last update posted

May 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VDI Technologies on 2026-05-05.