Key result
Leadless transcatheter pacemakers meet safety and efficacy goals with profiles similar to transvenous systems.
Why the study?
Does a leadless transcatheter pacemaker provide safe and effective pacing compared to historical performance goals in patients with indications for single-chamber ventricular pacing?
Does a leadless transcatheter pacemaker provide safe and effective pacing compared to historical performance goals in patients with indications for single-chamber ventricular pacing?
A leadless transcatheter pacemaker demonstrated high implantation success, met prespecified safety and efficacy goals at 6 months, and had fewer major complications compared to a historical transvenous pacemaker cohort.
May support leadless pacing in single-chamber candidates; extends observational data while leaving randomized comparisons open.
In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).
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Reynolds et al. (2015) studied this question. The leadless intracardiac transcatheter pacing system met safety and efficacy goals, with a safety profile similar to transvenous systems and low stable pacing thresholds.
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