Clinical Trial Advances Treatment for Leading Cause of Cardiac Arrest

The cardiac team at Virtua Our Lady of Lourdes Hospital recently became the first in the nation to implant an investigational defibrillation lead designed to treat people with ventricular tachycardia (VT), an abnormally fast, potentially life-threatening rhythm in the lower chambers of the heart.

Virtua is one of 47 hospitals worldwide participating in a clinical trial called the Lead Evaluation for Defibrillation and Reliability (LEADR). The LEADR study, sponsored by Medtronic, will evaluate the safety and effectiveness of an investigational, catheter-delivered lead in adult patients who have previously experienced, or are at significant risk of developing, VT. The lead is paired with commercially available Medtronic defibrillators.

Ventricular tachycardia occurs when a disorganized or chaotic electrical signal in the heart causes the ventricles to beat too quickly. The heart is unable to pump oxygen-rich blood to the rest of the body efficiently, leading to fainting, dizziness, shortness of breath, or chest pain. VT is responsible for many of the 350,000 sudden cardiac deaths in the United States each year.

People with VT often receive an implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) to interrupt or stop these dangerous rhythms. A thin wire, called a lead, is threaded through the veins and connects the device to the heart muscle. The lead senses the heart’s electrical signals, and transmits that information to the device, which detects rapid, potentially life-threatening heartbeats. If a dangerous heart rhythm is detected, the device quickly delivers therapy—in the form of painless pacing pulses or an electrical shock to the heart—to restore a normal rhythm.

“By participating in the LEADR study, we are helping drive patient care forward,” said Virtua heart rhythm specialist Aatish Garg, MD, who performed the first procedure with Darius Sholevar, MD, Virtua chief of electrophysiology and principal investigator. “ICDs and CRT-Ds are proven therapies that can save the lives of people who experience these dangerous heart rhythms that can lead to sudden cardiac arrest.”

The investigational lead is 1.6 millimeters in diameter, which means that it takes up less space in the veins compared to commercially available leads that are implanted with ICDs today.

“One of the issues we encounter with the larger leads used in ICDs is that the scar tissue that builds up around them over time can cause the veins in which they are inserted to become occluded,” said Dr. Sholevar. “This investigational lead is thinner.”

Participants in the study will be followed for a minimum of 18 months.

For more information about the LEADR study and potential enrollment, please contact Marisa Brown, study primary coordinator, at mbrown3@virtua.org.