Last updated on November 2017

The LEADLESS II Study


Brief description of study

The LEADLESS II Study

Detailed Study Description

Sponsor has developed a leadless cardiac pacemaker (LCP) system to eliminate leads, pockets, and connectors required by conventional pacemakers and to eliminate associated complications. This concept could improve patient comfort by replacing a surgical procedure with a percutaneous one, eliminating the visible lump and scar at a conventional pacemaker’s pectoral implant site, and removing the need for activity restrictions to prevent dislodgement after implantation of a conventional lead. Finally, the concept could permit pacemaker patients to undergo magnetic resonance imaging (MRI) with specified machines, although this is not being evaluated under this protocol.

Nanostim’s LCP system consists of a pacemaker and its accessories: a programmer, introducer, delivery catheter, and retrieval catheters. The accessories are not intended for use alone or with any device other than the Nanostim pacemaker. The pacemaker and all accessories, except the programmer, are single-use devices and are supplied sterile.

Clinical Study Identifier: TX8499

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Feather Wafford

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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