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

This study has been withdrawn prior to enrollment.
(Low Enrolment)
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: January 26, 2015
Last verified: January 2015
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Newmarket Electrophysiology Research Group Inc:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Enrollment: 0
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798277

Sponsors and Collaborators
Newmarket Electrophysiology Research Group Inc
Biosense Webster, Inc.
Investigators
Principal Investigator: Yaariv Khaykin, MD Newmarket Electrophysiology Research Group
  More Information

No publications provided

Responsible Party: Newmarket Electrophysiology Research Group Inc
ClinicalTrials.gov Identifier: NCT01798277     History of Changes
Other Study ID Numbers: NERG-02
Study First Received: February 20, 2013
Last Updated: January 26, 2015
Health Authority: Canada: Ethics Review Committee

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
Coronary Disease
Myocardial Ischemia
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases
Amiodarone
Anti-Arrhythmia Agents
Sotalol
 Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Autonomic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on February 25, 2015