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

Primary Purpose

Ventricular Tachycardia, Coronary Artery Disease

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Catheter Ablation
Medical therapy (sotalol or amiodarone)
Sponsored by
Newmarket Electrophysiology Research Group Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Catheter Ablation

    Medical therapy

    Arm Description

    Radiofrequency ablation procedure

    Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Total mortality
    Change in mortality status at 3, 6, 9 and 12 months after intervention
    Sudden cardiac death
    Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention
    Syncope
    Change in syncope status at 3, 6, 9 and 12 months after intervention
    Number of hospitalizations
    Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention
    QOL measures
    Change in QOL measures at 6 and 12 months after intervention

    Full Information

    First Posted
    February 20, 2013
    Last Updated
    January 26, 2015
    Sponsor
    Newmarket Electrophysiology Research Group Inc
    Collaborators
    Biosense Webster, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01798277
    Brief Title
    Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia
    Acronym
    VeTAMed
    Official Title
    Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Low Enrolment
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Newmarket Electrophysiology Research Group Inc
    Collaborators
    Biosense Webster, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventricular Tachycardia, Coronary Artery Disease
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Catheter Ablation
    Arm Type
    Active Comparator
    Arm Description
    Radiofrequency ablation procedure
    Arm Title
    Medical therapy
    Arm Type
    Active Comparator
    Arm Description
    Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.
    Intervention Type
    Procedure
    Intervention Name(s)
    Catheter Ablation
    Other Intervention Name(s)
    Ablation of:, - Ischemic ventricular tachycardia, - Sustained monomorphic ventricular tachycardia, - Clinical ventricular tachycardia, - Hemodynamically stable/unstable ventricular tachycardia
    Intervention Description
    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.).
    Intervention Type
    Drug
    Intervention Name(s)
    Medical therapy (sotalol or amiodarone)
    Other Intervention Name(s)
    Sotalol - Betapace, Betapace AF, Sotalex, Sotacor
    Intervention Description
    Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).
    Primary Outcome Measure Information:
    Title
    Recurrence of Ventricular Tachycardia
    Description
    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
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Time to First Shock/ATP for VT or to First Presentation of Sustained VT
    Description
    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
    Time Frame
    1 year
    Title
    Total mortality
    Description
    Change in mortality status at 3, 6, 9 and 12 months after intervention
    Time Frame
    1 year
    Title
    Sudden cardiac death
    Description
    Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention
    Time Frame
    1 year
    Title
    Syncope
    Description
    Change in syncope status at 3, 6, 9 and 12 months after intervention
    Time Frame
    1 year
    Title
    Number of hospitalizations
    Description
    Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention
    Time Frame
    1 year
    Title
    QOL measures
    Description
    Change in QOL measures at 6 and 12 months after intervention
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yaariv Khaykin, MD
    Organizational Affiliation
    Newmarket Electrophysiology Research Group
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia

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