The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a commercially available, standard of care electro-physiology (EP) monitoring and recording device during the pacemaker implantation. Participants receiving a routine de-novo implantation of a pacemaker for left bundle branch area pacing (LBBAP) will undergo the CSP Display System protocol during the implant procedure.
Subject is at least 18 years of age
Subject is willing and able to provide written informed consent
Subject is willing and able to comply with the protocol
Subject meets eligibility for de-novo implant of a pacemaker (single or dual chamber) with left bundle branch area pacing (LBBAP) therapy
Subject is not available to comply with visit schedule
Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
Subject is currently enrolled or planning to enroll in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
Subject meets any exclusion criteria required by local law
The target population for the CSP Display study will include subjects who are indicated to receive a de-novo pacemaker implant (single or dual chamber) with left bundle branch area pacing (LBBAP) based on market approved indications.
Cohort
Prospective
CSP Display research system
DeviceResearch system used during pacemaker implantation to visualize surface electrocardiogram data and automatically measure left ventricular activation time
Left Ventricular Activation Time (LVAT)
LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system
Surface ECG V1 morphology
V1 morphology observed using the CSP Display Research System and a commercial electrophysiology recording system.
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