A Safety and Effectiveness Trial for a Leadless Pacemaker System
A Safety and Effectiveness Trial for a Leadless Pacemaker System/Nanostim
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Clinical Trial Information
Trial Contact: Noel, Henry; Peisner, Pamela
Trial Phone: 321.841.3686 ; 321.843.1037
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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
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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.
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Key Eligibility
Clinical indication for a VVI(R) Pacemaker
