ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today 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, multi-center, randomized study evaluating the safety and efficacy of the 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.
“For many years, implantable cardioverter defibrillators have been one of the primary treatment options for patients with ventricular arrhythmias,” said Dr. Andrea Natale, executive medical director at 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.”
Patients who have ventricular tachycardia, an abnormal rapid heart rhythm that originates from the lower pumping chambers of the heart, may not be able to maintain a normal blood pressure because of the heart’s inability to effectively pump blood throughout the body. If a normal heart rate is not restored, patients may experience episodes of loss of consciousness, or even sudden cardiac death. An implantable ICD or CRT-D detects this abnormal heart rhythm and delivers a small shock to the heart that is intended to restore a normal rhythm. Today, ICDs and CRT-Ds are an effective treatment option for nearly all patients with life-threatening ventricular tachycardias, but patients with recurring symptoms may need adjunctive treatment options, such as catheter ablation or medication, to prevent the heart from going into VT.
“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,” said Srijoy Mahapatra, M.D., vice president of clinical, medical and scientific affairs at St. Jude Medical. “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.”
The STAR-VT trial will enroll an estimated 1,450 patients at approximately 50 centers in the U.S. 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 four to five years. The STAR-VT trial will evaluate the number of ICD or CRT-D interventions after one year post-procedure as well as the incidence of serious adverse events associated with catheter ablation within 30 days following 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, which will be used for ablation as indicated in the STAR-VT study, was designed with feedback from physician thought-leaders around the world and combines a unique, irrigated flexible catheter tip with a state-of-the-art handle and catheter design. The next-generation flexible tip technology 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 EnSite™ Velocity™ Cardiac Mapping System 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.
Ablation catheters are thin, flexible wires used to help treat irregular heartbeats that impair the heart's ability to effectively pump blood throughout the body. The FlexAbility catheter features an innovative handle and shaft that allows for improved maneuverability, enabling electrophysiologists to reach challenging anatomic locations within their patients, and is an investigational device in the United States.
An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD).
A CRT-D device resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients, and provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure. Studies have shown that CRT (cardiac resynchronization therapy) can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood.
The learn more about St. Jude Medical technologies at the twentieth annual International AF Symposium, visit us at booth 821 or visit us on the web for show-specific information at: http://www.sjm.com/af-symposium.
About St. Jude Medical
St. Jude Medical is a global medical
device manufacturer dedicated to transforming the treatment of some of
the world’s most expensive epidemic diseases. The company does this by
developing cost-effective medical technologies that save and improve
lives of patients around the world. Headquartered in St. Paul, Minn.,
St. Jude Medical has four major clinical focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com
or follow us on Twitter @SJM_Media.
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