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

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Renal sympathetic denervation; Device: VT ablation alone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15030
    • Homolka Hospital
• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal sympathetic denervation; Catheter-based Renal Sympathetic Denervation Ablation Arm	Device: Renal sympathetic denervation; 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).; Other Names: Ablation Arm; Catheter-based Renal Sympathetic Denervation
Placebo Comparator: VT ablation alone; No further therapy in addition to VT ablation	Device: VT ablation alone; Placebo arm will receive standard VT ablation using current techniques

What is the study measuring?

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 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
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 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

Collaborators and Investigators

• Sponsor: Vivek Reddy

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Catheter Ablation; Tachycardia, Renal Sympathetic Denervation; Cardioverter-Defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: GCO 13-1462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO