Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVDI Technologies
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants who are eligible for this study must have bradycardia or heart failure and are scheduled for pacemaker device implantation. Baseline ECG requirements must be met.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Ultra High Frequency Electrocardiogram (UHF-ECG)
DeviceElectrocardiograms used on participants scheduled to undergo pacemaker implantation for bradycardia and/or heart failure.
Treatment groups
360 Participants
are divided into 1 treatment groupGroup A: Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Predictive agreement between UHF-ECG and standard ECG
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.
Time frame
Pre-procedureSecondary outcomes
1
Predictive agreement in dyssynchrony between UHF-ECG and standard ECG
Predictive agreement of ventricular dyssynchrony and sidedness on the pre-procedure 12-lead ECG compared of UHF-ECG in participants with identified ventricular dyssynchrony.
Time frame
Pre-procedureSponsors and contacts
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Source ClinicalTrials.gov