Philippe Ritter1, Gabor Z Duray2, Shu Zhang3, Calambur Narasimhan4, Kyoko Soejima5, Razali Omar6, Verla Laager7, Kurt Stromberg7, Eric Williams7, Dwight Reynolds. 1. 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. 2. Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. 3. Clinical EP Lab and Arrhythmia Center, Fuwai Hospital, Beijing, China. 4. Division of Electrophysiology, Department of Cardiology, CARE Hospitals and CARE Foundation, Hyderabad, India. 5. Department of Cardiology, Kyorin University Hospital, Tokyo, Japan. 6. Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia. 7. Medtronic, Mounds View, MN, USA.
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. CLINICALTRIALSGOV REGISTRATION ID: NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved.
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. CLINICALTRIALSGOV REGISTRATION ID: NCT02004873. Published on behalf of the European Society of Cardiology. All rights reserved.
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