Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer | NCT07733960

NCT07733960

Overview

NCT ID: NCT07733960
Lead Sponsor: Medtronic Cardiac Rhythm and Heart FailureINDUSTRY
Official Title: Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
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
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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)

Central Contacts: Sr Director - Clinical Research and Medical Science, MedtronicContact
vinay.rajan@medtronic.com