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

Launched by VDI TECHNOLOGIES · Oct 11, 2024

Keywords

ClinConnect Summary

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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.