Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer

NCT07733960 | Recruiting FDA Device

• 1 other identifier: CSP Display Study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bradycardia

Keywords

Left bundle branch area pacing (LBBAP)

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Activation Time (LVAT)

  LVAT measured using the CSP Display Research System and a commercial electrophysiology recording system

  During pacemaker implant procedure

Secondary Outcomes (1)

• Surface ECG V1 morphology

  During pacemaker implant procedure

Study Arms (1)

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

Interventions

CSP Display research system DEVICE

Research system used during pacemaker implantation to visualize surface electrocardiogram data and automatically measure left ventricular activation time

Patients receiving a clinically indicated single- or dual-chamber pacemaker implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Vulnerable adults (i.e. subjects incapable of giving consent)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

Velammal Medical College Hospital and Research Institute

Madurai, Tamil Nadu, India

RECRUITING

Asian Institute of Gastroenterology(AIG) hospitals

Hyderabad, Telegana, India

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sr Director - Clinical Research and Medical Science, Medtronic

CONTACT

+91-2233074700; vinay.rajan@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: July 29, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)