An observational study in Bradycardia, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Recruiting at 2 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure (part of Medtronic) · Observational
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.
This feasibility study evaluates the use of the CSP Display Research System during single- or dual-chamber pacemaker implantation for left bundle branch area pacing (LBBAP). The system provides visualization of electrocardiogram data and automatic measurement of left ventricular activation time. Measurements using the CSP Display Research System will be compared with measurements obtained from a standard electrophysiology (EP) recording system used during the implant procedure as part of standard clinical practice. This study also includes exploratory collection of electrocardiogram, intracardiac electrogram, pacemaker marker channel, and left ventricular activation time data during the implant procedure to support future research and algorithm development. These data will be collected for exploratory purposes and do not have a pre-specified evaluation in this study.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 100 is below the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 240 studies on the registry; 4 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with left bundle branch area pacing will have measurements collected using the CSP Display Research System for visualisation of surface electrocardiogram data and automatic measurement of left ventricular activation time for comparison with a standard electrophysiology recording system.
Device: CSP Display research system
Research 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
Time frame: During pacemaker implant procedure
Surface ECG V1 morphology
V1 morphology observed using the CSP Display Research System and a commercial electrophysiology recording system.
Time frame: During pacemaker implant procedure
Plan to share: No
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