A Safety and Effectiveness Trial for a Leadless Pacemaker System

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

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Noel, Henry

    Trial Phone: 321.841.3686

  • IRB No: 13.200.12

    Principal Investigator: David Bello, MD

    Sub Investigators: Guguchev, Pavel MD

    Phase: Device: Significant Risk

    Age Group: Adult

    Secondary Protocol No: DC-02374 Rev F

    Treatment: Procedural

    Applicable Disease Sites: Heart

    Therapies Involved: Leadless pacemaker system

    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