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

Recruiting now

Conditions studied: Bradycardia, Heart Failure, Ventricular Dysfunction

In brief

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.

Key facts

Study ID

NCT06641362

Run by

VDI Technologies

People needed

360

Starts

2025-03-18

Expected to finish

2027-05-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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