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

Philippe Ritter, G. 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

Fingerprint

Safety
Miniaturization
Benchmarking
Femoral Vein
Heart Ventricles
Catheters
Technology
Equipment and Supplies
Lead
Datasets

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

The rationale and design of the Micra Transcatheter Pacing Study : Safety and efficacy of a novel miniaturized pacemaker. / Ritter, Philippe; Duray, G.; Zhang, Shu; Narasimhan, Calambur; Soejima, Kyoko; Omar, Razali; Laager, Verla; Stromberg, Kurt; Williams, Eric; Reynolds, Dwight.

In: Europace, Vol. 17, No. 5, 02.04.2015, p. 807-813.

Research output: Contribution to journalArticle

Ritter, P, Duray, G, 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, vol. 17, no. 5, pp. 807-813. https://doi.org/10.1093/europace/euv026
Ritter, Philippe ; Duray, G. ; Zhang, Shu ; Narasimhan, Calambur ; Soejima, Kyoko ; Omar, Razali ; Laager, Verla ; Stromberg, Kurt ; Williams, Eric ; Reynolds, Dwight. / The rationale and design of the Micra Transcatheter Pacing Study : Safety and efficacy of a novel miniaturized pacemaker. In: Europace. 2015 ; Vol. 17, No. 5. pp. 807-813.
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AU - Omar, Razali

AU - Laager, Verla

AU - Stromberg, Kurt

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