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

NCT ID: NCT01858194

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-09-01

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.

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.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Renal sympathetic denervation

Catheter-based Renal Sympathetic Denervation Ablation Arm

Group Type: EXPERIMENTAL

Renal sympathetic denervation

Intervention Type: 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).

VT ablation alone

No further therapy in addition to VT ablation

Group Type: PLACEBO_COMPARATOR

VT ablation alone

Intervention Type: DEVICE

Placebo arm will receive standard VT ablation using current techniques

Interventions

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).

Intervention Type: DEVICE

VT ablation alone

Placebo arm will receive standard VT ablation using current techniques

Intervention Type: DEVICE

Other Intervention Names

Ablation Arm; Catheter-based Renal Sympathetic Denervation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vivek Reddy

OTHER

Sponsor Role: lead

Responsible Party

Vivek Reddy

Director Cardiac Arrhythmia Service, Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vivek Y Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Homolka Hospital

Prague, , Czechia

Countries

United States; Czechia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 13-1462

Identifier Type: -

Identifier Source: org_study_id