Does percutaneous implantation of an entirely intracardiac leadless pacemaker meet pacing and sensing requirements in patients?
An entirely intracardiac leadless pacemaker successfully met pacing and sensing requirements, though device-related serious adverse events occurred in roughly 6.6% of patients.
The leadless cardiac pacemaker met prespecified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials.gov number, NCT02030418.).
Reddy et al. (Sun,) studied this question.