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.