A leadless pacemaker in the real-world setting: Patient profile and performance over time.

ABSTRACT:

Background

While prior Micra trials demonstrated a high implant success rate and favorable safety and efficacy results, changes in implant populations and safety over time is not well studied. The objective of this analysis was to report the performance of Micra in European and Middle Eastern patients and compare to the Micra Investigational Device Exemption (IDE) and Micra Post Approval Registry (PAR) studies.

Methods

The prospective, single-arm Micra Acute Performance European and Middle Eastern (MAP EMEA) registry was designed to further study the performance of Micra in patients from EMEA. The primary endpoint was to characterize acute (30-day) major complications. Electrical performance was analyzed. The major complication rate through 12 months was compared with the ID

SUBMITTER: Roberts PR 

PROVIDER: S-EPMC9885317 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature