CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Boston Scientific Vessix Renal Denervation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01747837
NCT01747837N/ACompleted

REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients

Vivek Reddy·interventional·Posted Dec 12, 2012·Updated Mar 4, 2020

In Brief

A clinical study evaluating Boston Scientific Vessix Renal Denervation System for Ventricular Tachycardia. Completed, enrolled 48 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Russia, United States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2012
Enrollment StartOct 22, 2015
Primary CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.6 years ago

Interventions

Boston Scientific Vessix Renal Denervation Systemdevice

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