Bradycardia, Heart Failure, Ventricular Dysfunction
Conditions
Brief summary
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.
Interventions
DEVICEUltra High Frequency Electrocardiogram (UHF-ECG)
Electrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Sponsors
VDI Technologies
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive agreement between UHF-ECG and standard ECG | Pre-procedure | Positive and negative predictive agreement between standard 12-lead ECG and UHF-ECG in discrimination of ventricular synchrony versus dyssynchrony with one recording per participant taken pre-procedure as evaluated by the core laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive agreement in dyssynchrony between UHF-ECG and standard ECG | Pre-procedure | Predictive agreement of ventricular dyssynchrony and sidedness on the pre-procedure 12-lead ECG compared of UHF-ECG in participants with identified ventricular dyssynchrony. |
Countries
Czechia, Netherlands, United States
Contacts
CONTACTRandy LaBounty
Outcome results
None listed