Baptist Health first in Northeast Florida to participate in clinical study for new pacemaker system

Baptist Health is the first health system in Northeast Florida to participate in the global Aveir™ DR i2iTM IDE Study, a clinical study designed to assess the safety and effectiveness of a new pacemaker system in patients with abnormal heart rhythms.

A normal heart beats regularly at a rate of 60 to 100 times per minute. People who experience a slower-than-normal or irregular heart rate may benefit from a pacemaker, which is a small battery-powered device implanted in the chest. In most pacemakers, electrical impulses are delivered via wires, called leads, which help the heart muscle restore a normal heart rhythm.

The pacemaker in this clinical study is unique because it is:

• Leadless: It delivers electrical impulses without the small wires, called “leads” used in traditional pacemakers.
• Dual Chamber: The pacemaker is placed in the heart’s right lower and upper chambers, whereas traditional pacemakers are only placed in one chamber.

An innovative algorithm allows the devices in the upper and lower chambers of the heart to communicate with each other to restore cardiac rhythm.

The new pacemaker is inserted into the heart via a minimally invasive procedure, making the hospital stay shorter and recovery time faster for patients.

Venkata Sagi, MD, FHRS, clinical cardiac electrophysiologist with Baptist Heart Specialists, is this study's principal investigator at Baptist Health and has implanted the first devices in four patients. He said, “Clinical trials allow us to bring the latest, innovative technology back to the people in our community. We were pleased to be the first in Northeast Florida to offer this option to patients through this study, and we look forward to seeing the results.”

The Aveir DR Leadless Pacemaker System is the world’s first true dual-chamber leadless pacemaker system. It is being clinically evaluated and is not yet commercially available. While enrollment for this clinical trial is now complete at Baptist Health, we are committed to bringing innovative treatment options via clinical trials to our community. Learn more by visiting Baptist Health Research Institute.