Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation

Study Overview
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Brief Summary
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Study hypothesis: With optimal medical therapy and repeated ablations, an additional renal denervation may have protective effects in terms of vegetative intrinsic activity and lead to a significant reduction in VT Burdens. Study design: Multicenter, randomized, prospective, single-blind clinical trial.

Detailed Description
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Study protocol: Catheter ablation of ventricular tachycardia versus combined catheter ablation of ventricular tachycardia and renal denervation. A total of 50 patients with ventricular tachycardia treated with ICD shocks or ATP will be enrolled in this study. The randomization in the study is done before ablation. For the ablation, an arterial access is required in both groups. During a 30 minutes waiting time which will apply to both groups, renal denervation will be performed. In this period of time operators and staff will be blinded for the procedure, thereby they won't know if the patients will receive a renal denervation, in that way the investigators are avoiding a bias of future treatment of the patients. Follow up and repeat procedures: All Patients will be followed for a period of 3, 6, 9, 12 and 18 months after the procedure. Regular visits are done in the investigators office. The visit will include ICD Interrogation, VT documentation in ICD Holter, 24-hour Holter ECG or Tele-ECGs, echocardiography. Re- VT ablations are allowed at any time. In case of renal artery stenosis, denervation will not be performed. Drug therapy can be continued.

Official Title
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Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation

Conditions
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Ventricular Tachycardia, Cardiomyopathy

Intervention / Treatment
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* Procedure: Ablation of ventricular arrhythmias
* Procedure: Ablation of ventricular arrhythmias + renal denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Ischemic cardiomyopathy NYHA II-III Recurrent ventricular tachycardia, ICD interventions (shock or ATP) Obtained written informed consent Exclusion Criteria: Age <18 years Previous VT ablation NYHA IV Cardiopulmonary decompensation within the last 4 weeks Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment History of hemorrhagic diathesis or other coagulopathies Contraindication for oral anticoagulation Hyper- or hypothyroidism Drug or chronic alcohol abuse Has any condition that would make participation not be in the best interest of the subject Incompliance

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 |
| --- | --- |
| Active Comparator: control group<br>Ablation of ventricular arrhythmias | Procedure: Ablation of ventricular arrhythmias<br>* control group: Ablation of ventricular arrhythmias<br>|
| Sham Comparator: intervention group<br>Ablation of ventricular arrhythmias + renal denervation | Procedure: Ablation of ventricular arrhythmias + renal denervation<br>* Intervention group: Ablation of ventricular arrhythmias + renal denervation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up | Number of Patients with adverse events such as recurrens of Ventricular | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up | Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up | 24 months | 
| Number of periprocedural complications | Number of periprocedural complications | 24 months |