Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia

Study Overview
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Brief Summary
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To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.

Detailed Description
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Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.

Official Title
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Randomized Controlled Phase IV Multicentric Trial, Comparing the Efficacy and Safety of Radiofrequency Substrate Ablation of Monomorphic Ventricular Tachycardia vs. Antiarrhyhtmic Drugs in Patients Experiencing Appropriate ICD Shocks

Conditions
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Monomorphic Ventricular Tachycardia

Intervention / Treatment
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* Procedure: Ablation
* Drug: Antiarrhythmic drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic cardiomyopathy, with ischemic myocardial scar Sustained monomorphic ventricular tachycardia Age > 18 years Prior ICD implantation Exclusion Criteria: VT storm NYHA functional class IV Additional indication for antiarrhythmic drug therapy Contraindication for both study drugs (amiodarone and sotalol). Uncontrolled myocardial ischemia. LV thrombus. Non-ischemic VT substrate. Contraindications for anticoagulation. Prior substrate ablation in the previous 6 months Cr > 2.5 mg/dL Mitral AND aortic mechanical valvular prosthesis

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation<br>Substrate-based radiofrequency catheter ablation | Procedure: Ablation<br>* Substrate-based radiofrequency catheter ablation<br>* Other names: Catheter Ablation;|
| Active Comparator: Antiarrhythmic drug therapy<br>Antiarrhythmic drug therapy; amiodarone or sotalol | Drug: Antiarrhythmic drug<br>* Amiodarone or sotalol therapy<br>* Other names: Amiodarone, Sotalol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of death from cardiovascular causes. | - Cause of death will be established by evaluation of medical records by an endpoints adjudication committee. Cardiovascular death includes: sudden death, death due to worsening heart failure or death due to myocardial infarction | 2 years | 
| Occurrence of appropriate shocks for VT/VF | Occurrence of appropriate shocks for VT/VF VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope). | 2 years | 
| Occurrence of hospitalization for heart failure | - Hospitalization for heart failure requiring overnight hospital stay and either increased oral diuretics or intravenous diuretics (at least 40 mg od frusemide or 10 mg od torasemide). | 2 years | 
| Occurrence of severe complication of the ablation procedure. | Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports | 2 years | 
| Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects | Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with appropriate ICD therapies | Occurrence of appropriate ICD therapies is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope). Appropriateness of ICD therapies is established by device-stored electrogram analysis performed by two expert independent electrophysiologists | 2 years | 
| Number of patients with inappropriate ICD therapies | Occurrence of ICD therapies is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope). Appropriateness of ICD therapies is established by device-stored electrogram analysis performed by two expert independent electrophysiologists | 2 years | 
| Number of patients with appropriate ICD shocks | Occurrence of ICD shocks is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope). Appropriateness of ICD shocks is established by device-stored electrogram analysis performed by two expert independent electrophysiologists | 2 years | 
| Number of patients with inappropriate ICD shocks | Occurrence of ICD shocks is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope). Appropriateness of ICD shocks is established by device-stored electrogram analysis performed by two expert independent electrophysiologists | 2 years | 
| Quality of life measured with the The Short Form (36) Health Survey | Quality of life is measured with the The Short Form (36) Health Survey at pre-specified study follow-up visits (3,6,12,24 months). The short-form (36) health survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular tachycardia, Ischemic cardiomyopathy, Catheter Ablation, Antiarrhythmic drug therapy, ICD