Parallel Mapping for Ventricular Tachycardia

Study Overview
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Brief Summary
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Catheter ablation in patients with ventricular tachycardia using a new mapping algorithm called, parallel mapping, that is aimed to increase the specificity of mapping and the outcome of ablation.

Detailed Description
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In patients with scar in the hearts after heart attacks, the risk for dangerous abnormal heart rhythms, including sudden death is high. This is because dead muscle fibers are replaced by scar tissue, creating a physiological condition promoting abnormal heart rhythms.These abnormal heart rhythms are called ventricular arrhythmias or ventricular tachycardias. In these patients, ablation procedures can be helpful, however the recurrence rate of arrhythmias after ablation remains unacceptably high. The primary reason for this high recurrence rate is nonspecific mapping methodologies for identifying the heart area responsible for these arrhythmias. Therefore, new methods for increasing the specificity of mapping have been the subject of significant research for many years, however implementation of these methods in clinical practice has been challenged by limited technologies. Recently, a new mapping technology named parallel mapping has been developed, received FDA approval and is routinely utilized at the Cleveland Clinic. However, the workflow of using parallel mapping, and the efficacy of ablation using this technology have not been evaluated.

Official Title
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Ablation of Ventricular Tachycardia Guided by Multi-site Pacing Using Parallel Mapping

Conditions
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Ventricular Tachycardia (V-Tach), Implantable Cardioverter Defibrillator (ICD), Arrythmia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years History of scar-mediated sustained ventricular tachycardia Failure of therapy with Anti arrhythmic drugs Implanted ICD or a plan for ICD implantation after the ablation Willingness to adhere to the study restrictions and comply with all post procedural follow-up requirements Ability to understand the requirements of the study and sign an informed consent Exclusion Criteria: Patients with reversible causes of ventricular tachycardia including ongoing ischemia or electrolyte abnormalities Contraindication to anticoagulation therapy Stroke within 30 days before enrollment Life expectancy <1 year Individual has a known, unresolved history of drug use or alcohol dependency lacks the ability to comprehend or follow instructions or would be unlikely or unable to comply with study follow-up requirements Pregnant or breast feeding at time of signing consent Patient undergoing cardiac transplantation Enrolled or participates in other drug or device studies

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single procedure freedom from ventricular recurrence at 1 year | Number of VT | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from implantable cardioverter defibrillator (ICD) shocks | Number of ICD shocks | 12 months | 
| Reduction in mapping time using parallel mapping algorithm | Minutes | 12 months | 
| Reduction in radiofrequency ablation time | Minutes | 12 months |