The rationale and design of the Micra Transcatheter Pacing Study: Safety and efficacy of a novel miniaturized pacemaker

Philippe Ritter, Gabor Z. Duray, Shu Zhang, Calambur Narasimhan, Kyoko Soejima, Razali Omar, Verla Laager, Kurt Stromberg, Eric Williams, Dwight Reynolds

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Aims Recent advances in miniaturization technologies and battery chemistries have made it possible to develop a pacemaker small enough to implant within the heart while still aiming to provide similar battery longevity to conventional pacemakers. The Micra Transcatheter Pacing System is a miniaturized single-chamber pacemaker system that is delivered via catheter through the femoral vein. The pacemaker is implanted directly inside the right ventricle of the heart, eliminating the need for a device pocket and insertion of a pacing lead, thereby potentially avoiding some of the complications associated with traditional pacing systems. Methods and results The Micra Transcatheter Pacing Study is currently undergoing evaluation in a prospective, multi-site, single-arm study. Approximately 720 patients will be implanted at up to 70 centres around the world. The study is designed to have a continuously growing body of evidence and data analyses are planned at various time points. The primary safety and efficacy objectives at 6-month post-implant are to demonstrate that (i) the percentage of Micra patients free from major complications related to the Micra system or implant procedure is significantly higher than 83% and (ii) the percentage of Micra patients with both low and stable thresholds is significantly higher than 80%. The safety performance benchmark is based on a reference dataset of 977 subjects from 6 recent pacemaker studies. Conclusions The Micra Transcatheter Pacing Study will assess the safety and efficacy of a miniaturized, totally endocardial pacemaker in patients with an indication for implantation of a single-chamber ventricular pacemaker. ClinicalTrials.gov registration ID NCT02004873.

Original languageEnglish
Pages (from-to)807-813
Number of pages7
JournalEuropace
Volume17
Issue number5
DOIs
Publication statusPublished - Apr 2 2015

Keywords

  • Delivery catheter
  • Leadless pacemaker
  • Miniaturization
  • Pacemaker
  • Transcatheter pacing system

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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    Ritter, P., Duray, G. Z., Zhang, S., Narasimhan, C., Soejima, K., Omar, R., Laager, V., Stromberg, K., Williams, E., & Reynolds, D. (2015). The rationale and design of the Micra Transcatheter Pacing Study: Safety and efficacy of a novel miniaturized pacemaker. Europace, 17(5), 807-813. https://doi.org/10.1093/europace/euv026