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A Safety and Effectiveness Trial for a Leadless Pacemaker System

A Safety and Effectiveness Trial for a Leadless Pacemaker System/Nanostim

  • Clinical Trial Information

    Trial Contact: Noel, Henry; Anthony, Susan; Peisner, Pamela; Tinetti, Meghan

  • IRB No: 13.200.12

    Protocol Abbrev: LEADLESS II

    Principal Investigator: Luis Isaac Garcia, MD

    Phase: Device: Significant Risk

    Age Group: Adult

    Secondary Protocol No: SJM-CIP-10226/Rev M

    Treatment: Leadless pacemaker system

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT02030418

  • Objective

    The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the apex of the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.

  • Key Eligibility

    Clinical indication for a VVI(R) Pacemaker