Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer

ConditionBradycardia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Rhythm and Heart Failure

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CSP Display research system

Treatment groups

100 Participants
are divided into 1 treatment group