Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators

Study Overview
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Brief Summary
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The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.

Official Title
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Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators

Conditions
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Ventricular Tachycardia, Ischemic

Intervention / Treatment
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* Drug: Drug Treatment
* Device: Catheter Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite drug therapy) a. Subject must be on at least one AAD at time of enrollment Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction ICD implanted 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator History of myocardial infarction documented by the development of pathological Q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction 18 years or older Able and willing to comply with all pre- and follow-up testing and requirements Signed Informed Consent Form Exclusion Criteria: Age < 18 years Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours) Contraindication to anticoagulation NYHA class IV Left ventricular assist devices (LVADs) or other circulatory assist devices Stroke as confirmed by plasma d-dimer levels or acute myocardial infarction as documented by electrocardiogram or cardiac imaging within the past three (3) months. (Note that a small cardiac enzyme release resulting from being in VT/shocks/etc. is not considered a myocardial infarction.) Patients with active ischemia who are eligible for revascularization Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy) Other disease process likely to limit survival to less than 12 months Serum creatinine of ≥ 2.5mg/dl Thrombocytopenia or coagulopathy Prior ablation for Ventricular Tachycardia Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) Enrollment in an study evaluating an investigational device or drug Unable or unwilling to comply with protocol requirements Exclusively Polymorphic Ventricular Tachycardia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>This group receives radiofrequency catheter ablation and drug treatment. | Device: Catheter Ablation<br>* Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.<br>|
| Experimental: Control Group<br>This group receives only drug treatment. | Drug: Drug Treatment<br>* Class I and III antiarrhythmic drug treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events | The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure. | From one month to 2 years follow up | 
| Cardiac-related Death | Subjects with cardiac-related death | 2 years follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic, Ventricular Tachycardia, Implantable Cardioverter Defibrillators, Antiarrhythmic Drug Therapy, Ablation, Electrophysiology