Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CSP Display research system.
- Who it may be relevant to
- Registry conditions: Bradycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Device CSP Display research system
Research system used during pacemaker implantation to visualize surface electrocardiogram data and automatically measure left ventricular activation time
Primary outcome measures
- Left Ventricular Activation Time (LVAT) [Time frame: During pacemaker implant procedure]
Secondary outcome measures (1)
- Surface ECG V1 morphology [Time frame: During pacemaker implant procedure]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
India · 2 centers
- Velammal Medical College Hospital and Research Institute — Madurai
- Asian Institute of Gastroenterology(AIG) hospitals — Hyderabad
Identifiers
NCT: NCT07733960 · CSP Display Study