Ultra-high-frequency ECG to diagnose ventricular electrical dyssynchrony in patients getting pacemakers

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

This test checks whether an ultra-high-frequency ECG can safely and accurately detect ventricular dyssynchrony in adults with bradycardia or heart failure who are having their first pacemaker implanted.

Quick facts

• Study type: Observational
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VDI Technologies (industry)
• Locations: 12 sites (Avondale, Arizona and 11 other locations)
• Trial ID: NCT06641362 on ClinicalTrials.gov

What this trial studies

This observational study compares a novel ultra-high-frequency electrocardiogram (UHF-ECG) measurement to the standard 12-lead ECG in patients scheduled for first-time pacemaker implantation, including CRT or conduction system pacing. UHF-ECG recordings will be obtained around the time of the implant and analyzed for signs of ventricular electrical dyssynchrony, with results compared against conventional ECG findings. The primary aims are to demonstrate the safety of using the VDI UHF-ECG System in this setting and its diagnostic effectiveness relative to the 12-lead ECG. Data will be collected at several centers, including community and academic sites, to evaluate performance across typical clinical settings.

Who should consider this trial

Good fit: Adults with bradycardia or heart failure who are scheduled for their first pacemaker implantation (including CRT or conduction system pacing) and who meet the specified conduction-pattern criteria are ideal candidates.

Not a fit: Patients with a prior pacemaker or defibrillator, those with complete AV block without a stable escape rhythm, or anyone unable to undergo a reliable 12-lead ECG are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, UHF-ECG could help clinicians better identify patients with ventricular dyssynchrony and guide pacemaker or CRT decisions, potentially improving cardiac function and patient outcomes.

How similar studies have performed: The UHF-ECG approach is relatively novel; small research reports suggest it can detect intraventricular dyssynchrony, but large-scale clinical validation versus the 12-lead ECG is still limited.

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.

Where this trial is running

Avondale, Arizona and 11 other locations

• Peak Heart and Vascular — Avondale, Arizona, United States (RECRUITING)
• Banner Medical Center — Mesa, Arizona, United States (RECRUITING)
• University of Chicago — Chicago, Illinois, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• Ohio State University — Columbus, Ohio, United States (RECRUITING)
• Baylor College of Medicine — Houston, Texas, United States (RECRUITING)
• University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
• Fakultní nemocnice Brno — Brno, Czechia (RECRUITING)
• St. Anne's University Hospital — Brno, Czechia (RECRUITING)
• Na Homolce Hospital — Prague, Czechia (RECRUITING)
• Fakultni Nemocnice Královské Vinohrady — Prague, Czechia (RECRUITING)
• Catherina Ziekenhuis — Eindhoven, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Randy LaBounty

Conditions: Bradycardia, Heart Failure, Ventricular Dysfunction