REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

Study Overview
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Brief Summary
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Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.

Detailed Description
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The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.

Official Title
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REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Renal sympathetic denervation
* Device: VT ablation alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.) Planned for catheter-based ablation of VT All patients will have an existing ICD Accessibility of renal vasculature (determined by renal angiography) Ability to understand the requirements of the study Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements Exclusion Criteria: MI or CVA within 30 days Coronary Artery Bypass Graft (CABG) within 30 days of this procedure Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis) GFR <30 ml/min (unless receiving dialysis) Life expectancy <1 year for any medical condition Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding) Inability to give informed consent Known pregnancy or positive -HCG within 7 days of procedure.

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: Renal sympathetic denervation<br>Catheter-based Renal Sympathetic Denervation Ablation Arm | Device: Renal sympathetic denervation<br>* The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a spiral pattern, see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).<br>* Other names: Catheter-based Renal Sympathetic Denervation;|
| Placebo Comparator: VT ablation alone<br>No further therapy in addition to VT ablation | Device: VT ablation alone<br>* Placebo arm will receive standard VT ablation using current techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From First Event Requiring ICD Therapy | Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Procedure-related Adverse Events | Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction. | 24 months | 
| Changes in Mean Arterial Pressure | Change in mean arterial pressure | baseline and 24 months | 
| Number of Participants With Orthostatic Hypertension | Number of participants with other individual complication rates specifically orthostatic hypertension | 24 months | 
| Number of Participants With Other Complications | Other individual complication rates including, but not limited to MI and death | at 24 months | 
| Number of Occurrences of Major Complication Rate | 30-day Major Complication Rate defined as death, stroke, MI or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer) | 30 days | 
| Procedure Time | Renal Denervation Procedure time | during procedure | 
| Number of Participants With Hospitalizations for Cardiovascular Causes |  | 24 months | 
| Number of Episodes of Total VT Burden | Total VT burden (Number of episodes) | at 24 months | 
| Number of Participants With All-Cause Mortality |  | 24 months | 
| Number of Participants With Occurrences of ICD Storm | The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours. | 24 months | 
| Change in Brain Natriuretic Peptide (BNP) | Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline. | at baseline and at 12 months | 
| Differences in BUN/Creatinine Measurements | Differences in BUN/creatinine measurements compared at 12 months to baseline. | baseline and 12 months | 
| Change in LV Size | LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline | baseline and 12 months | 
| Number of Appropriate ICD Shocks for Ventricular Arrhythmia | An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation. | at 24 months | 
| Number of Inappropriate ICD Therapy | Number of inappropriate ICD therapy including both appropriate and inappropriate shocks | at 24 months | 
| All ICD Therapies (Appropriate + Inappropriate) | cumulative ICD therapies including both appropriate and inappropriate shocks | 24 months | 
| Number of Participants With Mortality, ICD Storm and Incessant VT | Number of Participants with a composite of Mortality, ICD storm, and Incessant VT | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tachycardia, Renal Sympathetic Denervation, Catheter Ablation, Cardioverter-Defibrillator