Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
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.
RATE CONTROL VERSUS RHYTHM CONTROL FOR POSTOPERATIVE ATRIAL FIBRILLATION
The purpose of the research is to compare two strategies for treating atrial fibrillation or
atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most
common complication after cardiac surgery. AF is when the upper chambers of the heart (atria)
experience disorganized electrical activity which causes the heart beat to be irregular. The
two treatment strategies to be used in this study are called rhythm control and rate control.
The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm
using treatments known and approved to control heart rhythm. The rate control strategy will
attempt to bring the heart rate to less than 100 beats per minute at rest using medications
known and recommended to control heart rate. Both strategies are commonly used to treat AF.
All of the medications that will be used in this study are the standard of care for use in
patients experiencing AF. This research seeks to determine whether rhythm control is better
than rate control in patients with AF after cardiac surgery.