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

RecruitingObservational study

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: VDI Technologies · Participants: 360 · Started: Mar 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06641362

Locations in the U.S.

ArizonaPeak Heart and Vascular, Avondale
Banner Medical Center, Mesa
IllinoisUniversity of Chicago, Chicago
MinnesotaMayo Clinic, Rochester
OhioOhio State University, Columbus
TexasBaylor College of Medicine, Houston
VirginiaUniversity of Virginia, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.