Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not yet clarified. The incidence of appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can result in the prognostic improvement.To suppress ventricular arrhythmias aside from antiarrhythmic agents, catheter ablation has been developed prominently in this decade along with the technological improvement such as irrigated ablation catheters, three-dimensional mapping systems, multi-polar catheters, and image integration system with CT and MRI. The rationale of this trial is to study the efficacy of the eradication of arrhythmogenic substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of the occurrence of sustained VT/VF and ICD therapies.

Official Title
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Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Conditions
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Ventricular Tachycardia, Ischemic Cardiomyopathy, Reduced LVEF

Intervention / Treatment
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* Procedure: VT ablation
* Other: medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: left ventricular ejection fraction (TTE or MRI) ≤40% diagnosed ischemic heart disease nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring ICD implantation with primary preventive indication Exclusion Criteria: ICD implantation within 2 months previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock no written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VT ablation group<br> | Procedure: VT ablation<br>* Substrate mapping for VT will be performed with the CARTO electroanatomical system.<br>|
| medication group<br> | Other: medication<br>* medication to prevent sustained VT and ICD therapies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of sustained VT/VF or ICD therapy | occurrence of sustained VT/VF or ICD therapy including ATP and shock | time from randomization to occurrence of any sustained VT/VF within 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival free from clinical events | survival free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm, defined as more than three VT episodes in 24 hours) | time from randomization to 24 months | 
| number of appropriate ICD therapies | number of appropriate ICD therapies (ATP or shock) | time from randomization to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic cardiomyopathy, prophylactic ablation