Conduction System Pacing Display Research During LBBAP Implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a feasibility, observational study conducted during de-novo LBBAP pacemaker implants to compare the CSP Display Research System's ECG visualization and left ventricular activation time measurements with those obtained from a standard EP recording system. The study collects exploratory data such as ECG, intracardiac signals, pacemaker marker channels, and LV activation times to support future research and algorithm development. No pre-specified endpoints are evaluated beyond descriptive comparisons and data collection during the implant procedure. The CSP system is used as an adjunct in the procedure, with measurements analyzed against standard clinical practice for feasibility purposes.

Why it matters

Who can join: the full rules

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)

Where it's running

• Velammal Medical College Hospital and Research Institute
  Madurai, Tamil Nadu, India Recruiting
• Asian Institute of Gastroenterology(AIG) hospitals
  Hyderabad, Telegana, India Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.