REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients

Status: Completed
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• ≥ 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

Locations
United States
New York
Mount Sinai Hospital
New York
Texas
Texas Cardiac
Austin
Other Locations
Russian Federation
Academician E.N. Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Novosibirsk
Time Frame
Start Date: 2015-10-22
Completion Date: 2019-01-09
Participants
Target number of participants: 48
Treatments
No_intervention: standard ICD implantation alone
These subjects will undergo standard ICD implantation alone (if not already present)
Experimental: Boston Scientific Vessix Renal Denervation System
These subjects will undergo standard ICD implantation (if not already present) plus renal sympathetic denervation.~Ablation arm
Sponsors
Leads: Vivek Reddy

This content was sourced from clinicaltrials.gov