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UHF-ECG for Diagnosing Ventricular Electrical Dyssynchrony

This study is looking at a new way to diagnose a heart condition called ventricular electrical dyssynchrony (VED) using a special heart test called Ultra-High Frequency Electrocardiogram (UHF-ECG). Researchers want to see how well the UHF-ECG compares to the standard 12-lead ECG in patients who have bradycardia (slow heart rate) or heart failure and are scheduled to get a pacemaker. You might be able to join if you are an adult with bradycardia or heart failure and are scheduled for your first pacemaker implant. The study will be considered successful if the UHF-ECG results match the standard ECG results. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 360 participants. It compares the UHF-ECG device to a standard ECG.
What's involved
You would undergo an Ultra High Frequency Electrocardiogram (UHF-ECG) before your pacemaker procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured pre-procedure, so long-term follow-up is not specified.

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NCT06641362

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

Recruiting
Not specifiedAges 18+Observational
VDI Technologies
~360 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Ultra High Frequency Electrocardiogram (UHF-ECG)

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Predictive agreement between UHF-ECG and standard ECG
Measured over Pre-procedure

Conditions

Bradycardia
Heart Failure
Ventricular Dysfunction

Explore related trials

BradycardiaHeart FailureVentricular Dysfunction

Where it's being run

12 sites across 8 states
Czechia4
Arizona2
Illinois1
Minnesota1
Ohio1
Texas1
Virginia1
Netherlands1

Who to contact

Randy LaBounty
[email protected]
9529136050
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Predictive agreement between UHF-ECG and standard ECGPre-procedure

    Positive and negative predictive agreement between standard 12-lead ECG and UHF-ECG in discrimination of ventricular synchrony versus dyssynchrony with one recording per participant taken pre-procedure as evaluated by the core laboratory.