Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia (VeTAMed)

Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)

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

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Ventricular Tachycardia
• Intervention / Treatment: Procedure: Catheter Ablation; Drug: Medical therapy (sotalol or amiodarone)

Detailed Description

This is a multicenter, randomized prospective cohort study to compare the impact of catheter ablation with antiarrhythmic drug therapy for treating patients with sustained ventricular tachycardia (VT) and coronary artery disease. Patients that meet all inclusion criteria and no exclusion criteria will be recruited to the study cohort. After baseline measurements are taken, patients will be randomized in a 2:1 fashion to either undergo radiofrequency catheter ablation or receive antiarrhythmic drug therapy (amiodarone or sotalol). The in-clinic appointments include: enrollment, baseline, intervention, and follow-up every three months for one year post-ablation. At each follow-up visit, electrogram (ECG) and Holter monitoring tests will be performed to measure any episodes of ventricular tachyarrhythmia. Furthermore, interrogation of the patient's implantable cardioverter defibrillator (ICD) will be performed at all follow-up visits to detect any episodes of ventricular tachyarrhythmia that required antitachycardia pacing (ATP) or shocks.

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Catheter Ablation; Radiofrequency ablation procedure	Procedure: Catheter Ablation; Catheter 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.).; Other Names: Ablation of:; - Ischemic ventricular tachycardia; - Sustained monomorphic ventricular tachycardia; - Clinical ventricular tachycardia; - Hemodynamically stable/unstable ventricular tachycardia
Active Comparator: Medical therapy; Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.	Drug: Medical therapy (sotalol or amiodarone); Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).; Other Names: Sotalol - Betapace, Betapace AF, Sotalex, Sotacor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of Ventricular Tachycardia	Number of any appropriate ATPs/shocks and/or presentations of sustained (>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Shock/ATP for VT or to First Presentation of Sustained VT	Change in time to first ATP/shock or presentation of sustained (>30sec) VT on Holter or ECG recording at 3, 6, 9 and 12 months after intervention	1 year
Total mortality	Change in mortality status at 3, 6, 9 and 12 months after intervention	1 year
Sudden cardiac death	Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention	1 year
Syncope	Change in syncope status at 3, 6, 9 and 12 months after intervention	1 year
Number of hospitalizations	Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention	1 year
QOL measures	Change in QOL measures at 6 and 12 months after intervention	1 year

Collaborators and Investigators

• Sponsor: Newmarket Electrophysiology Research Group Inc
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Yaariv Khaykin, MD, Newmarket Electrophysiology Research Group

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Additional relevant MeSH terms:; Pathologic Processes; Atrial Fibrillation; Coronary artery disease; Cardiovascular Diseases; Ablation; Pharmacologic Actions; Heart Diseases; Therapeutic Uses; Ventricular tachycardia; Amiodarone; Anti-Arrhythmia Agents; Ischemic heart disease; Arrhythmias, Cardiac; Sotalol; Catheter Ablation, Radiofrequency; Ventricular tachyarrhythmia; Keywords provided by Newmarket Electrophysiology Research Group Inc:
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Tachycardia; Tachycardia, Ventricular; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Sympatholytics; Potassium Channel Blockers; Amiodarone; Sotalol
• Other Study ID Numbers: NERG-02