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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ventricular Tachycardia; Coronary Artery Disease	Procedure: Catheter Ablation; Drug: Medical therapy (sotalol or amiodarone)	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)
Study Start Date :	April 2013
Estimated Primary Completion Date :	June 2015
Estimated Study Completion Date :	December 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Sotalol - Betapace, Betapace AF, Sotalex, Sotacor

Outcome Measures

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Primary Outcome Measures :

1. Recurrence of Ventricular Tachycardia [ Time Frame: 1 year ]
   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

Secondary Outcome Measures :

1. Time to First Shock/ATP for VT or to First Presentation of Sustained VT [ Time Frame: 1 year ]
   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
2. Total mortality [ Time Frame: 1 year ]
   Change in mortality status at 3, 6, 9 and 12 months after intervention
3. Sudden cardiac death [ Time Frame: 1 year ]
   Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention
4. Syncope [ Time Frame: 1 year ]
   Change in syncope status at 3, 6, 9 and 12 months after intervention
5. Number of hospitalizations [ Time Frame: 1 year ]
   Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention
6. QOL measures [ Time Frame: 1 year ]
   Change in QOL measures at 6 and 12 months after intervention

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Newmarket Electrophysiology Research Group Inc

Biosense Webster, Inc.

Investigators

Principal Investigator:	Yaariv Khaykin, MD	Newmarket Electrophysiology Research Group

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Newmarket Electrophysiology Research Group Inc
ClinicalTrials.gov Identifier:	NCT01798277 History of Changes
Other Study ID Numbers:	NERG-02
First Posted:	February 25, 2013
Last Update Posted:	January 27, 2015
Last Verified:	January 2015

Keywords provided by Newmarket Electrophysiology Research Group Inc:

Keywords provided by Newmarket Electrophysiology Research Group Inc: Ventricular tachycardia; Ventricular tachyarrhythmia; Ablation; Coronary artery disease; Ischemic heart disease; Amiodarone; Sotalol; Anti-Arrhythmia Agents	Therapeutic Uses; Pharmacologic Actions; Additional relevant MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Catheter Ablation, Radiofrequency

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Tachycardia; Tachycardia, Ventricular; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Amiodarone; Anti-Arrhythmia Agents; Sotalol

Vasodilator Agents; Potassium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Sodium Channel Blockers; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents