Application of High Power Radio Frequency Energy in the Ventricular Tachycardia Treatment

Study Overview
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Brief Summary
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Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure. Hypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease. Purpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy.

Detailed Description
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Background: Patient's freedom from VT after RFA remains non-optimal and it depends on many factors. One of them is the effective reduction of the myocardium with RF energy during the operation. The standardization of the parameters of RF will help to increase the success of the procedure. Hypothesis: Radiofrequency ablation of ventricular tachycardias with high power parameters has comparable safety and leads to greater efficacy (absence of ventricular tachycardias and all types of cardioverter-defibrillator therapies) in the long-term compared with ablation with standard parameters in patients with structural heart disease. Purpose: to evaluate the safety and the efficiency of ablation of ventricular tachycardia in patients with structural heart disease using high power RF energy. Tasks: To analyze the number of intraoperative complications in both groups To evaluate the number of recurrent ventricular tachycardias and the number of episodes of CDI therapy in the long-term follow-up period To estimate the time of onset of the first episode of VT and the overall burden of VT in the long-term follow-up period To compare the total time of surgery, fluoroscopy, the number and total time of RF exposure, as well as the ablation index in relation to the acute and separated efficiency of ablation in the study groups To estimate all-cause mortality in both groups The number of repeated ablation for recurrent VT The number of justified and unfounded CDI therapies To analyze the long-term burden of antiarrhythmic therapy

Official Title
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Application of High Power Radio Frequency Energy in the Interventional Treatment of Patients With Ventricular Tachycardia and Structural Heart Disease

Conditions
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Ventricular Tachycardia, Heart Diseases

Intervention / Treatment
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* Procedure: High power ablation
* Procedure: Standard ablation power


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after myocardial infarction (at least 3 months before enrollment in the study) Stable, documented, monomorphic VT, confirmed by ECG and / or CMECG and / or EGM of any implanted device, having appropriate rhythm discrimination algorithms Patients who have signed the informed consent Exclusion Criteria: Acute myocardial ischemia A reversible cause of VT (e.g. drug arrhythmia), recently(up to 30 days) suffered from acute coronary syndrome, coronary revascularization (<90 days for bypass surgery, <30 days for percutaneous coronary intervention), or having functional class IV angina. Thrombosis of the left ventricle Patients who have been implanted the mechanical prostheses in the aortic and mitral positions. Patients who have been performed the catheter RFA for VT. Renal failure (creatinine clearance <15 ml / min), Patients with NYHA functional class IV heart failure Patients with a medical condition that may limit survival to less than 1 year Patients with myocardial infarction with ST-segment elevation or MI without ST-segment elevation, transferred less than 30 days ago. Patients who haven't signed the informed consent

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 |
| --- | --- |
| Experimental: High power ablation<br>High power ablation parameters (50-55 W) | Procedure: High power ablation<br>* High power ablation parameters (50-55 W)<br>|
| Active Comparator: Standard ablation power<br>Standard ablation power parameters (40-45 W) | Procedure: Standard ablation power<br>* Standard ablation power parameters (40-45 W)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of intraoperative complications | The number of intraoperative complications (death, hemopericardium, stroke, heart attack, electrical storm, vascular complications) | Day 1 | 
| The inducibility of the clinical VT at the end of ablation procedure | The number of patients with inducible VT at the end of the ablation procedure | Day 1 | 
| The number of recurrent ventricular tachycardias | The number of recurrent ventricular tachycardias on one-year follow-up period after single procedure | Up to one year | 
| The number of episodes of ICD therapy | The number of episodes of ICD therapy on one-year follow-up period after single procedure | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from recurrent VT | Time to the first episode of VT on 3 months follow-up period after single procedure | 3 months | 
| The total time of ablation procedure | The total time of ablation procedure | Up to one year | 
| The total time of fluoroscopy | The total time of fluoroscopy | Up to one year | 
| The total number of RF exposures | The total number of RF exposures | Up to one year | 
| The total time of RF exposures | The total time of RF exposures | Up to one year | 
| All-cause mortality | All-cause mortality (Time to any death occurring at any time on one-year follow-up period ) | Up to one year | 
| The number of redo ablation procedures for recurrent VT | The number of redo ablation procedures for recurrent VT on one-year follow-up period | Up to one year | 
| The number of appropriate and unappropriated ICD therapies | The number of appropriate and unappropriated ICD therapies | Up to one year | 
| The number of antiarrhythmic drugs | The number of antiarrhythmic drugs on one-year follow-up period | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Power Radio Frequency Energy, Ventricular Tachycardia, Structural Heart Disease