St. Jude Medical (NYSE:STJ) said it enrolled its 1st patient in a clinical trial designed to evaluate the use of ablation in conjunction with cardiac rhythm management devices in treating ventricular tachycardia.
The Star-VT trial is slated to enroll some 1,450 patients at 50 U.S. sites. All patients enrolled with receive either an implantable cardiac defibrillator or a cardiac resynchronization therapy defibrillator; the control arm will receive drug treatment alone for ventricular arrhythmia, while the control arm will receive ablation therapy using St. Jude’s FlexAbility ablation catheter, according to a press release.
St. Jude said the Star-VT trial will evaluate the number of ICD or CRT-D interventions after 1 year post-procedure as well as the incidence of serious adverse events associated with catheter ablation within 30 days following the procedure. The trial will also assess the reduction of emergency room visits and mortality rates for patients involved in the trial, according to the release.
"While other studies have indicated that early ablation therapy can help prevent ventricular tachycardia recurrence and may reduce ICD shocks, a large randomized trial focusing on a high-risk patient group has been needed to better assess the efficacy of this treatment option in order to reduce heart failure hospitalizations, mortality and health care costs," vice president of clinical, medical and scientific affairs Dr. Srijoy Mahapatra said in prepared remarks. "We look forward to gathering evidence that supports our belief that the addition of catheter ablation in this patient population is a safer, more efficacious and cost effective option for patients than routine drug and implantable defibrillator therapy alone when treating complex ventricular arrhythmias.”
“For many years, implantable cardioverter defibrillators have been one of the primary treatment options for patients with ventricular arrhythmias," added Dr. Andrea Natale of the Texas Cardiac Arrhythmia Institute. "While these are life-saving therapies, patient risks associated with the recurrence of ventricular tachycardia, such as frequent shocks from an implantable defibrillator, still exist. This study is important because it may provide further evidence that ablation therapies are more effective than medication in suppressing recurring ventricular tachycardia and, with it, the freedom from shocks and repeat cardiovascular hospitalizations for my patients."