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

NCT01858194 | Completed Results DMC

• 1 other identifier: GCO 13-1462
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Ventricular Tachycardia

Keywords

Tachycardia, Renal Sympathetic Denervation; Catheter Ablation; Cardioverter-Defibrillator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Number of Appropriate ICD Shocks for Ventricular Arrhythmia

  at 24 months

• Number of Inappropriate ICD Therapy

  at 24 months

• All ICD Therapies (Appropriate + Inappropriate)

  24 months

• Number of Participants With Mortality, ICD Storm and Incessant VT

  24 months

• Number of Participants With Hospitalizations for Cardiovascular Causes

  24 months

Study Arms (2)

Renal sympathetic denervation

EXPERIMENTAL

Catheter-based Renal Sympathetic Denervation Ablation Arm

Device: Renal sympathetic denervation

VT ablation alone

PLACEBO COMPARATOR

No further therapy in addition to VT ablation

Device: VT ablation alone

Interventions

Renal sympathetic denervation DEVICE

* 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).

Also known as: Ablation Arm, Catheter-based Renal Sympathetic Denervation

Renal sympathetic denervation

VT ablation alone DEVICE

Placebo arm will receive standard VT ablation using current techniques

VT ablation alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead

Study Sites (2)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Homolka Hospital

Prague, 15030, Czechia

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Betsy Ellsworth, Research Program Director
• Organization: Icahn School of Medicine at Mo

betsy.ellsworth@mountsinai.org

212 824 8902

Study Officials

• Vivek Y Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Cardiac Arrhythmia Service, Professor of Medicine

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: May 21, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 17, 2020
• Results First Posted: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CZ (1)