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

Launched by VDI TECHNOLOGIES · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new heart test called the VDI UHF-ECG system, which aims to better detect a condition called ventricular electrical dyssynchrony—a problem where parts of the heart don’t beat in sync. This is important for people with slow heartbeats (bradycardia) or heart failure who may need a pacemaker or a special type of therapy to help their heart beat more effectively. The study will compare this new test to the standard 12-lead ECG, which is a common heart monitoring tool, to see if the new system is safe and works well.

Adults aged 65 to 74 with certain types of slow heart rhythms or heart failure that qualify them for pacemaker or cardiac resynchronization therapy may be eligible to join. Participants will need to understand the study, agree to take part, and meet specific heart rhythm criteria. During the study, participants will have their heart tested using both the new VDI UHF-ECG system and the standard ECG. This helps doctors learn if the new test provides better or additional information. People with certain heart conditions, previous pacemakers, or other health issues that might interfere with the tests won’t be included. Overall, this study hopes to improve how doctors diagnose heart rhythm problems to provide better treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Adults with bradycardia scheduled for pacemaker implant or heart failure patients indicated for cardiac resynchronization therapy (CRT) with one of the following:
• • Bradycardia with ventricular synchrony and QRS duration \< 110 ms in men or \< 100 ms in women or;
• • Bradycardia with left bundle branch block and QRS duration \> 140 ms in men or \> 130 ms in women or;
• • Bradycardia with right bundle branch block and QRS duration \> 130 ms in men or \> 120 ms in women or;
• • Heart failure with left bundle branch block and QRS duration \> 140 ms in men or \>130 ms in women.
• • 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.