The rationale and design of the Micra Transcatheter Pacing Study: safety and efficacy of a novel miniaturized pacemaker
| Autor: | Gabor Z. Duray, Dwight Reynolds, Razali Omar, Philippe Ritter, Eric R. Williams, Calambur Narasimhan, Kyoko Soejima, Shu Zhang, Kurt Stromberg, Verla Laager |
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| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
Pacemaker Artificial Time Factors Femoral vein Risk Assessment Clinical Protocols Risk Factors Physiology (medical) Internal medicine Medicine Humans In patient Major complication Prospective Studies Lead (electronics) Miniaturization business.industry Cardiac Pacing Artificial Arrhythmias Cardiac Equipment Design Surgery Ventricular pacemaker Catheter Treatment Outcome Research Design Cardiology Implant Cardiology and Cardiovascular Medicine business Reference dataset |
| Zdroj: | Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 17(5) |
| ISSN: | 1532-2092 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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