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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Newmarket Electrophysiology Research Group Inc
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Newmarket Electrophysiology Research Group Inc
ClinicalTrials.gov Identifier:
NCT01798277
First received: February 20, 2013
Last updated: June 21, 2013
Last verified: June 2013

February 20, 2013
June 21, 2013
April 2013
June 2015   (final data collection date for primary outcome measure)
Recurrence of Ventricular Tachycardia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01798277 on ClinicalTrials.gov Archive Site
  • Time to First Shock/ATP for VT or to First Presentation of Sustained VT [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in mortality status at 3, 6, 9 and 12 months after intervention
  • Sudden cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in sudden cardiac death status at 3, 6, 9 and 12 months after intervention
  • Syncope [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in syncope status at 3, 6, 9 and 12 months after intervention
  • Number of hospitalizations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in number of hospitalizations at 3, 6, 9 and 12 months after intervention
  • QOL measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in QOL measures at 6 and 12 months after intervention
Same as current
Not Provided
Not Provided
 
Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ventricular Tachycardia
  • Coronary Artery Disease
  • 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
  • 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
  • Active Comparator: Catheter Ablation
    Radiofrequency ablation procedure
    Intervention: Procedure: Catheter Ablation
  • Active Comparator: Medical therapy
    Antiarrhythmic drug therapy will include amiodarone or sotalol. Which antiarrhythmic drug will prescribed per patient depends on the observing physician.
    Intervention: Drug: Medical therapy (sotalol or amiodarone)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Lauren Chun, MSc 905-895-4521 ext 5012 lchun@southlakeregional.org
Canada
 
NCT01798277
NERG-02
No
Newmarket Electrophysiology Research Group Inc
Newmarket Electrophysiology Research Group Inc
Biosense Webster, Inc.
Principal Investigator: Yaariv Khaykin, MD Newmarket Electrophysiology Research Group
Newmarket Electrophysiology Research Group Inc
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP