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Lehigh Valley Heart and Vascular Institute Participating in World-Wide Implantable Cardiac Defibrillator Study

Only site in Pennsylvania evaluating use of catheter-delivered heart technology in LEADR clinical trial

the Lead Evaluation for Defibrillation and Reliability (LEADR) clinical trial

Lehigh Valley Heart and Vascular Institute is among about 50 sites worldwide involved in evaluating the use of an investigational, catheter-delivered lead in adult patients who have previously experienced, or are at significant risk for developing, life-threatening ventricular tachycardia (VT).

What is ventricular tachycardia?

VT is an arrhythmia – an abnormal rhythm – in the lower chambers of the heart. It occurs when your heart beats too fast – more than 100 beats per minute – which can affect the flow of oxygen-rich blood to the rest of your body. It’s an important cause of sudden death and occurs most commonly in those with preexisting structural heart disease.

Symptoms include dizziness, shortness of breath, lightheadedness, palpitations and chest pain.

More about the clinical trial

Lehigh Valley Heart and Vascular Institute is the only site in Pennsylvania engaged in the Lead Evaluation for Defibrillation and Reliability (LEADR) clinical trial sponsored by Medtronic. The investigational lead will be paired with commercially available Medtronic defibrillators. The trial is investigational because the catheter-based lead is not yet approved by the Food and Drug Administration (FDA). The trial is expected to last about 18 months.

Patients with VT often receive an implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) to interrupt or terminate dangerous, racing 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.

According to Medtronic, the novelty of the defibrillation lead under study is that it is threaded through the veins and into the heart through a catheter, which helps with placing the lead.

Why we’re involved

“We’re pleased to be part of this important clinical study exploring an innovative approach for helping our patients,” said Ronald Freudenberger, MD, Physician in Chief, Lehigh Valley Heart and Vascular Institute. “It’s important to keep driving research for patients suffering from arrhythmias, and we are optimistic about seeing the results of the LEADR study and its potential impact on treatment options.”

Cardiologist Babak Bozorgnia, MD, of Lehigh Valley Heart and Vascular Institute, was one of the first cardiologists in the U.S. to take part in the trial.

More people in the region trust Lehigh Valley Heart and Vascular Institute with their cardiac care than any of our competitors, according to the Pennsylvania Health Care Cost Containment Council.

Patients with VT who qualify for this study will be asked to sign an informed consent form before receiving the investigational lead.

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