N/A
N=48
REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT01747837 ↗Enrolled (actual)
48
Serious AEs
43.8%
Results posted
Jan 2020
Primary outcome: Primary: Time to First Event Requiring ICD Therapy or Incessant VT — 177.2; 148.66 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Boston Scientific Vessix Renal Denervation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vivek Reddy
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Event Requiring ICD Therapy or Incessant VT |
177.2; 148.66 | — |
| SECONDARY Number of Occurrences of Appropriate ICD Therapy |
46; 122 | — |
| SECONDARY Number of Occurrences of Inappropriate ICD Therapy |
388; 86 | — |
| SECONDARY Number of Hospitalizations for Cardiovascular Causes |
11; 9 | — |
| SECONDARY Number of Episodes of Total VT Burden |
513; 671 | — |
| SECONDARY All-Cause Mortality |
4; 4 | — |
| SECONDARY Number of Occurrence of ICD Storm |
1; 2 | — |
| SECONDARY BUN Measurements |
13.31; 10.6; 12; 11.71; 10.02; 8.71 | — |
| SECONDARY Creatinine Measurements |
105; 102; 108; 108; 110; 104 | — |
| SECONDARY Procedure Related Adverse Events |
2; 7 | — |
| SECONDARY Number of Participants With Orthostatic Hypotension |
0; 0 | — |
| SECONDARY Number of Participants With Major Complication |
0; 3 | — |
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 Criteria
Inclusion Criteria
- ≥ 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01747837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.