Study of VDIs Ultra-High Frequency Electrocardiogram to Diagnose Ventricular Electrical Dyssynchrony in Adults with Bradycardia or Heart Failure Comparing UHF-ECG with Standard 12-Lead ECG in Patients Needing a Pacemaker

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the VDI UHF-ECG System for diagnosing ventricular dyssynchrony in patients with bradycardia and heart failure who are scheduled for pacemaker implantation. This observational study compares the new Ultra High Frequency Electrocardiogram UHF-ECG device with the standard 12-lead ECG to see how well it predicts electrical dyssynchrony in the heart. Participants will undergo both the standard ECG and the UHF-ECG measurements sequentially before their pacemaker procedure. The study focuses on adults with specific heart conditions such as bradycardia with different conduction patterns or heart failure with left bundle branch block. The investigational device is used to gather detailed electrical activity data to improve diagnosis. During the study, researchers will collect and compare ECG data from both devices before the pacemaker implant. Participants will be monitored for predictive agreement between the UHF-ECG and standard ECG results. The study involves informed consent, adherence to study procedures, and a pregnancy test for women of childbearing potential. The trial is expected to continue until May 2027.

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