Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
Recruiting now
Conditions studied: Bradycardia
In brief
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.
Key facts
- Study ID
- NCT07733960
- Run by
- Medtronic Cardiac Rhythm and Heart Failure
- People needed
- 100
- Starts
- 2026-05-21
- Expected to finish
- 2027-07-30
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Velammal Medical College Hospital and Research Institute — Madurai, Tamil Nadu, India (enrolling)
- Asian Institute of Gastroenterology(AIG) hospitals — Hyderabad, Telegana, India (enrolling)
Full record on ClinicalTrials.gov
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