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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01798277
Recruitment Status : Withdrawn (Low Enrolment)
First Posted : February 25, 2013
Last Update Posted : January 27, 2015
Biosense Webster, Inc.
Information provided by (Responsible Party):
Newmarket Electrophysiology Research Group Inc

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.

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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

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

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01798277

Sponsors and Collaborators
Newmarket Electrophysiology Research Group Inc
Biosense Webster, Inc.
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Principal Investigator: Yaariv Khaykin, MD Newmarket Electrophysiology Research Group
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Responsible Party: Newmarket Electrophysiology Research Group Inc Identifier: NCT01798277    
Other Study ID Numbers: NERG-02
First Posted: February 25, 2013    Key Record Dates
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
Coronary artery disease
Ischemic heart disease
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:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Anti-Arrhythmia Agents
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