CSP Display research system: Research system used during pacemaker implantation to visualize surface electrocardiogram data and automatically measure left ventricular activation time
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Vulnerable adults (i.e. subjects incapable of giving consent)
Primary outcome measure(s)
Left Ventricular Activation Time (LVAT) — During pacemaker implant procedure LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system
Trial sites (2)
Facility
City
Region
Status
Velammal Medical College Hospital and Research Institute
Madurai
Tamil Nadu
Recruiting
Asian Institute of Gastroenterology(AIG) hospitals
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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