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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?

Ventricular Tachycardia

Coronary Artery Disease

Study Interventions

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).

Study Arms

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.

Study Status

Withdrawn

Start Date: April 2013

Completed Date: December 2015

Phase: Phase 3

Type: Interventional

Design:

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.

More information:https://clinicaltrials.gov/show/NCT01798277

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