title: The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker.
abstract: OBJECTIVE
  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.
  
  
  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.
  NCT02004873.
authors: Department of Cardiac Pacing and Electrophysiology, CHU/Université de Bordeaux, Avenue Magellan, 33604 Pessac, France L'Institut de Rythmologie et de Modélisation Cardiaque LIRYC, CHU/Université de Bordeaux/INSERM U1045, Pessac, France ritterph@free.fr.
authors: Philippe
authors: P
authors: Ritter
authors: Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
authors: Gabor Z
authors: GZ
authors: Duray
authors: Clinical EP Lab and Arrhythmia Center, Fuwai Hospital, Beijing, China.
authors: Shu
authors: S
authors: Zhang
authors: Division of Electrophysiology, Department of Cardiology, CARE Hospitals and CARE Foundation, Hyderabad, India.
authors: Calambur
authors: C
authors: Narasimhan
authors: Department of Cardiology, Kyorin University Hospital, Tokyo, Japan.
authors: Kyoko
authors: K
authors: Soejima
authors: Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia.
authors: Razali
authors: R
authors: Omar
authors: Medtronic, Mounds View, MN, USA.
authors: Verla
authors: V
authors: Laager
authors: Medtronic, Mounds View, MN, USA.
authors: Kurt
authors: K
authors: Stromberg
authors: Medtronic, Mounds View, MN, USA.
authors: Eric
authors: E
authors: Williams
authors: Dwight
authors: D
authors: Reynolds
mesh_terms: D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects; D002985:Clinical Protocols; D004867:Equipment Design; D006801:Humans; D008904:Miniaturization; D010138:Pacemaker, Artificial / Q000009:adverse effects; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: Delivery catheter; Leadless pacemaker; Miniaturization; Pacemaker; Transcatheter pacing system