Overview
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.
Eligibility
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.