Groundbreaking Clinical Trial on Dual-Chamber Leadless Pacemaker

May 30, 2022

Dr. Banker is the principal investigator or PI of a groundbreaking first-ever study of a dual-chamber leadless pacemaker. If this device is ultimately FDA approved, it would be the world’s first and significant step forward in pacemaker technology and miniaturization. To understand how significant this is, it’s essential to discuss existing pacemaker technology and its limitations.

You probably have a traditional pacemaker in mind when you think of a pacemaker. A pulse generator or battery is a bit bigger than a quarter with leads sticking out from it. For decades, this has been the gold standard in pacing technology. While these peacemakers do their jobs very well, the leads going from the pacemaker to the heart can malfunction or break over time. This requires a surgical lead extraction and is not an ideal outcome. To address this, there are now tiny leadless pacemakers inserted into the left ventricle or lower chamber of the heart that do not require any wires and attach to the heart muscle wall. They offer similar battery life and have made pacing the heart more convenient and less intrusive for patients.

However, even these leadless pacemakers have a significant drawback: they can only be placed in a single heart chamber. Therefore, if the patient requires dual-chamber pacing, we are limited to using a traditional pacemaker.

With the possible introduction of this novel and groundbreaking device, we may be able to pace two heart chambers with a single device without the need for wires. This will genuinely give patients a full range of pacing options regardless of their condition.

We will keep you posted on how this study progresses and its eventual results.