STAR-VT Study Will Evaluate St. Jude Medical's FlexAbility Ablation Catheter

January 7, 2015—St. Jude Medical, Inc. announced the first patient enrollment in the STAR-VT (Substrate Targeted Ablation Using the FlexAbility Ablation Catheter System for the Reduction of Ventricular Tachycardia) clinical trial, a prospective, multicenter, randomized study evaluating the safety and efficacy of the company’s FlexAbility ablation catheter when used in ventricular tachycardia (VT) ablation procedures. The STAR-VT trial will assess whether combining targeted ablation with either an implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) can reduce the incidence and economic burden of recurring ventricular arrhythmias better than treatment with either an ICD or CRT-D and medication alone.

According to the company, the STAR-VT trial will enroll an estimated 1,450 patients at approximately 50 centers in the United States. International centers will also be included in the trial. All patients will receive an ICD or a CRT-D and will then be randomized 1:1 to either adjunctive treatment (ablation therapy) or control (routine drug therapy) groups. The anticipated enrollment duration is 4 to 5 years. The STAR-VT trial will evaluate the number of ICD or CRT-D interventions after 1 year postprocedure as well as the incidence of serious adverse events associated with catheter ablation within 30 days after the procedure. Other secondary endpoints will assess the reduction of emergency room visits and mortality rates for patients involved in the trial.

The FlexAbility ablation catheter is an investigational device in the United States.The device includes an irrigated flexible catheter tip that was designed to reduce complications associated with ablation procedures through its ability to bend and conform to the cardiac anatomy, decreasing the amount of pressure distributed to a patient's heart wall while simultaneously increasing the stability of therapy delivery. The FlexAbility catheter's handle and shaft allows for improved maneuverability, enabling electrophysiologists to reach challenging anatomic locations within their patients, according to St. Jude Medical.

The EnSite Velocity cardiac mapping system (St. Jude Medical) will be used in the trial to create the heart geometry and provide information for detection and diagnosis of abnormal heart rhythms in order to assist physicians in the targeting of ablation.

In the company’s press release, Andrea Natale, MD, commented, “For many years, implantable cardioverter defibrillators have been one of the primary treatment options for patients with ventricular arrhythmias. While these are life-saving therapies, patient risks associated with the recurrence of VT, 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 VT and, with it, the freedom from shocks and repeat cardiovascular hospitalizations for my patients.” Dr. Natale is Executive Medical Director at the Texas Cardiac Arrhythmia Institute in Austin, Texas.