Ohio State treats Midwest’s first patient in a trial of novel ventricular tachycardia device

The Ohio State University Wexner Medical Center is the first center in the Midwest to enroll and treat a patient in a new clinical trial using a novel device designed to treat recurrent ventricular tachycardia (VT), a serious heart rhythm disorder.

Despite advances in treatment for VT, more effective tools are needed. Early study results are promising because they show this new type of catheter is safe and effective for patients and potentially a more efficient procedure for physicians."

Rami Kahwash, MD, clinical director of Ohio State's heart and vascular research and professor of clinical medicine, The Ohio State University College of Medicine

Ventricular tachycardia occurs when an electrical signal is sent from the ventricles (lower chambers of the heart) at a very fast rate and sometimes stops the heart from properly filling with blood. Since not enough blood is being pumped to the body, VT can cause shortness of breath or lightheadedness. Episodes lasting longer than a few seconds can be life-threatening and lead to sudden cardiac arrest.

VT treatment includes medication, an implantable device inserted under the skin that sends an electric shock to restore the heart rhythm or cardiac ablation where a catheter (a thin flexible wire) is inserted into the heart and uses energy to destroy abnormal heart tissue causing the arrythmia.

During an ablation, electrophysiologists map the heart, deliver treatment and check to see if the irregular heart rhythm has stopped. In the national Sphere-9 clinical trial, Ohio State electrophysiologists used a mapping system and catheter created by Medtronic that does all three functions during an ablation without exchanging the catheter. The catheter also allows electrophysiologists to use either radiofrequency (heat-based) or non-thermal pulsed electric fields to help the heart restore its regular rhythm. Last April the FDA granted breakthrough device designation to the investigational device. The designation is intended to speed up the development and review of certain devices that may provide more effective treatment for life-threatening or disabling conditions.

"If the trial proves successful, this technology could make mapping and ablation much more efficient and potentially more effective. It also gives us a choice of what type of energy to use that will be most effective based on the patient's anatomy and advancement of disease," said Shrinivas Hebsur, MD, an electrophysiologist who performed the procedure Oct. 16 and is the trial's site principal investigator.

This clinical trial is the latest example of the Ohio State Wexner Medical Center being among the first to try new treatments to help patients suffering from irregular heart rhythms, Kahwash said. Last year Ohio State was the first in the U.S. to enroll a patient in the international ELEVATE-HFpEF trial testing a novel pacemaker program. In 2020, Ohio State electrophysiologists were the first in the U.S. to use pulsed field ablation technology to treat patients with atrial fibrillation.

The Ohio State Wexner Medical Center is home of the Bob and Corinne Frick Center for Heart Failure and Arrhythmia, the nation's first center dedicated to treating those with heart failure and arrhythmia.