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Conduction System Pacing Display System in Measuring device parameters during the Pacemaker implant procedure.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086854
Enrollment
100
Registered
2025-05-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I499- Cardiac arrhythmia, unspecified

Interventions

Intervention1: CSP Display research System: The Conduction System Pacing (CSP) Display Research System is a modified SmartSync Pacing System Analyzer (PSA) with the CSP Display Investigational Softwar

Sponsors

India Medtronic Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject is at least 18 years of age 2. Subject is willing and able to provide written informed consent 3.Subject is willing and able to comply with the protocol 4. Subject meets eligibility for de-novo pacemaker implant (single or dual chamber) with left bundle branch area pacing (LBBAP) therapy using the Model 3830 lead

Exclusion criteria

Exclusion criteria: 1. Subject is not available to comply with visit schedule 2. 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) 3. 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. 4. Subject meets any exclusion criteria required by local law 5. Vulnerable adults (i.e. subjects incapable of giving consent)

Design outcomes

Primary

MeasureTime frame
Compare the automatic LVAT measurement from surface ECG of the CSP Display research system to manual LVAT measurement of ECG from a commercial EP recording system during the procedure of pacemaker implant with LBBAPTimepoint: Pacemaker implant procedure—

Secondary

MeasureTime frame
1. Compare surface ECG V1 morphology between the CSP Display research system & a commercial EP recording system during a pacemaker implant with LBBAP.Timepoint: Pacemaker implant procedure;Collect ECG, EGM, Marker channel, & LVAT data from the SmartSync PSA system, & 12-lead ECG & EGM from a commercial system for future CSP algorithm developmentTimepoint: Pacemaker implant procedure—

Countries

India

Contacts

Public ContactVinay Rajan

India Medtronic Pvt Ltd

vinay.rajan@medtronic.com9619332703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026