Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer (CSP Display)

July 24, 2026 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sr Director - Clinical Research and Medical Science, Medtronic
  • Phone Number: +91-2233074700
  • Email: vinay.rajan@medtronic.com

Study Locations

  • India
    • Tamil Nadu
      • Madurai, Tamil Nadu, India
        • Recruiting
        • Velammal Medical College Hospital and Research Institute
        • Contact:
        • Principal Investigator:
          • Shunmuga Sundaram
    • Telegana
      • Hyderabad, Telegana, India
        • Recruiting
        • Asian Institute of Gastroenterology(AIG) hospitals
        • Contact:
        • Principal Investigator:
          • Calambur Narasimhan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients receiving a clinically indicated single- or dual-chamber pacemaker implantation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Activation Time (LVAT)
Time Frame: During pacemaker implant procedure
LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system
During pacemaker implant procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface ECG V1 morphology
Time Frame: During pacemaker implant procedure
V1 morphology observed using the CSP Display Research System and a commercial electrophysiology recording system.
During pacemaker implant procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP Display Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe