REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients

NCT01747837 | Completed Results DMC

• 1 other identifier: 12-02-213
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 4

Brief Summary

The objective of this trial is to determine the efficacy and safety of adjunctive catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii) primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular stimulation at the time of ICD implantation. These patients will be randomized to ICD alone or ICD + RSDN.

Conditions

Ventricular Tachycardia

Keywords

Renal sympathetic denervation; Renal catheter ablation; Ventricular tachycardia

Outcome Measures

Primary Outcomes (1)

• Time to First Event Requiring ICD Therapy or Incessant VT

  The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.

  24 months

Secondary Outcomes (11)

• Number of Occurrences of Appropriate ICD Therapy

  24 months

• Number of Occurrences of Inappropriate ICD Therapy

  24 months

• Number of Hospitalizations for Cardiovascular Causes

  24 months

• Number of Episodes of Total VT Burden

  24 months

• All-Cause Mortality

  24 months

Study Arms (2)

standard ICD implantation alone

NO INTERVENTION

These subjects will undergo standard ICD implantation alone (if not already present)

Boston Scientific Vessix Renal Denervation System

EXPERIMENTAL

These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation. Ablation arm

Device: Boston Scientific Vessix Renal Denervation System

Interventions

Boston Scientific Vessix Renal Denervation System DEVICE

Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation. Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts

Also known as: Renal sympathetic denervation, Renal denervation, Denervation

Boston Scientific Vessix Renal Denervation System

Eligibility Criteria

• Age: 18 Years - 85 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, etc.)
• Planned for ICD implantation for:
• i. Secondary prevention (eg: VT/VF arrest, sustained VT, syncope/inducible VT)
• ii. Primary prevention + inducible MMVT during induction via ICD lead testing
• 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:

• Patient taking a Class I or III antiarrhythmic drug.
• Planned to undergo a cardiac VT ablation procedure
• NYHA Class IV Congestive Heart Failure
• MI within 30 days
• Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
• Baseline orthostatic hypotension
• End stage renal failure on dialysis
• Life expectancy \<1 year for any medical condition
• Known pregnancy or positive β-HCG within 7 days of procedure.
• Coronary Artery Bypass Graft (CABG) within 30 days of the procedure

Sponsors & Collaborators

• Vivek Reddy: lead

Study Sites (4)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Texas Cardiac

Austin, Texas, 78705, United States

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Denervation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Sam Commack
• Organization: Icahn School of Medicine at Mount Sinai

sam.cammack@mountsinai.org

212-824-8931

Study Officials

• Vivek 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: November 1, 2012
• First Posted: December 12, 2012
• Study Start: October 22, 2015
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: March 4, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CZ (1); RU (1)