Ventricular Tachycardia | Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia
Ventricular Tachycardia research study
What is the primary objective of this study?
This study aims to compare antiarrhythmic drug therapy with catheter ablation using the SmartTOUCH catheter (Biosense Webster Inc.) as treatment for patients with ventricular tachycardia and coronary artery disease
Who is eligible to participate?
Inclusion Criteria: - Sustained monomorphic VT (>30 seconds, or requiring appropriate ICD therapy in patients with ICDs) - Documented ischemic heart disease with no further options for revascularization - Ability and willingness to give written informed consent to participate in the trial Exclusion Criteria: - VT in the setting of metabolic abnormalities or acute ischemia if coronary lesions suitable for revascularization are identified. - Acute ischemia with eligibility for revascularization - Significant peripheral arterial disease preventing transvascular access to the left ventricle. - Patients with arrhythmogenic right ventricular cardiomyopathy (ARVC), hypertrophic cardiomyopathy, Brugada syndrome, Long QT syndromes, dilated cardiomyopathy - Prior long term therapy with a Class III or Class IC antiarrhythmic agent (longer than 2 weeks) - Patient is or may be potentially pregnant - Patient has a mechanical heart valve - Myocardial infarction within the past 90 days - Stroke within the past 90 days - New York Heart Association (NYHA) functional class IV - Hemorrhagic manifestations, bleeding diathesis, or impairment of hemostasis - Lesions at risk of clinically significant bleeding (e.g., extensive cerebral infarction within the last 6 months, active peptic ulcer disease with recent bleeding) - Prior VT ablation procedure - Contraindication or allergy to contrast media, routine procedural medications or catheter materials - Contraindications to an interventional procedure - Life expectancy is less than 6 months - Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation - Untreated hypothyroidism or hyperthyroidism (euthyroid or thyroid hrt is acceptable) - Current enrolment in another investigational drug or device study - There are other conditions present that the investigator feels would be problematic or would restrict or limit the participation for the patient for the entire study period - Absolute contraindication to the use of heparin or warfarin - Documented intra-arterial thrombus, ventricular thrombus, (less than 6 months after detection of thrombus), tumor or other abnormality that precludes catheter introduction
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Coronary Artery Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Catheter AblationCatheter ablation of ventricular tachycardia will employ three-dimensional mapping Fast Anatomical Mapping or CARTOSOUND technology (Biosense Webster Inc.), and the Thermocool Navistar catheter (Biosense Webster Inc.).
Drug:Medical therapy (sotalol or amiodarone)Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Catheter AblationRadiofrequency ablation procedure
Medical therapyAntiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.
Start Date: April 2013
Completed Date: December 2015
Phase: Phase 3
Primary Outcome: Recurrence of Ventricular Tachycardia
Secondary Outcome: Time to First Shock/ATP for VT or to First Presentation of Sustained VT
Study sponsors, principal investigator, and references
Principal Investigator: Yaariv Khaykin, MD
Lead Sponsor: Newmarket Electrophysiology Research Group Inc
Collaborator: Biosense Webster, Inc.