Clinical trial NCT01798277: Trial Comparing Ablation With Medical Therapy in Patients With Ventricular Tachycardia
Official title: Ablation Versus Medical Therapy in Patients With Coronary Artery Disease and Sustained Ventricular Tachycardia Randomized Trial (VeTAMed)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: 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
Lead sponsor: Newmarket Electrophysiology Research Group Inc
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2013-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recurrence of Ventricular Tachycardia
timeFrame: 1 year
Secondary outcomes:
measure: Time to First Shock/ATP for VT or to First Presentation of Sustained VT
timeFrame: 1 year
measure: Total mortality
timeFrame: 1 year
measure: Sudden cardiac death
timeFrame: 1 year
measure: Syncope
timeFrame: 1 year
measure: Number of hospitalizations
timeFrame: 1 year
measure: QOL measures
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Newmarket Electrophysiology Research Group
name: Yaariv Khaykin, MD
role: PRINCIPAL_INVESTIGATOR
References: