A safety and effectiveness trial for a leadless pacemaker system

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.

September 25, 2015

  • Clinical Trial Information

    Trial Contact: Noel, Henry

    Trial Phone: 321.841.3686

  • Age Group: Adult

    Phase: Device: Significant Risk

    Principal Investigator: David Bello, MD

    Sub Investigators: Pavel A. Guguchev, MD;

    IRB No: 13.200.12

    Secondary Protocol No: DC-02374 Rev F

    Applicable Disease Sites: Chronic Atrial Fibrillation