REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients

Completed · Not applicable

Conditions studied: Ventricular Tachycardia

In brief

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.

Key facts

Study ID

NCT01747837

Run by

Vivek Reddy

People needed

48

Starts

2015-10-22

Expected to finish

2019-01-09

Last updated by the study team

2020-03-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Mount Sinai Hospital — New York, New York, United States
• Texas Cardiac — Austin, Texas, United States
• Na Homolce Hospital — Prague, Czechia
• Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology — Novosibirsk, Russia

Full record on ClinicalTrials.gov

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