The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

Status Completed

Clinical Trial Summary

Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker. Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.

Clinical Trial Description

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 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. ;

Study Design

Related Conditions & MeSH terms

Bradycardia

Clinical Trial Details

NCT number	NCT02030418
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	February 2014
Completion date	July 15, 2022

View Details

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