N/A
N=17
REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT01858194 ↗Enrolled (actual)
17
Serious AEs
29.4%
Results posted
Apr 2020
Primary outcome: Primary: Freedom From First Event Requiring ICD Therapy — 62.5; 50; 62.5; 37.5 probability of freedom
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Renal sympathetic denervation (Device); VT ablation alone (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vivek Reddy
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From First Event Requiring ICD Therapy |
62.5; 50; 62.5; 37.5 | — |
| SECONDARY Number of Appropriate ICD Shocks for Ventricular Arrhythmia |
7; 12 | — |
| SECONDARY Number of Inappropriate ICD Therapy |
5; 7 | — |
| SECONDARY All ICD Therapies (Appropriate + Inappropriate) |
32; 32 | — |
| SECONDARY Number of Participants With Mortality, ICD Storm and Incessant VT |
1; 3 | — |
| SECONDARY Number of Participants With Hospitalizations for Cardiovascular Causes |
3; 1 | — |
| SECONDARY Number of Episodes of Total VT Burden |
20; 12 | — |
| SECONDARY Number of Participants With All-Cause Mortality |
0; 0 | — |
| SECONDARY Number of Participants With Occurrences of ICD Storm |
1; 3 | — |
| SECONDARY Change in Brain Natriuretic Peptide (BNP) |
-12.33; -2.5 | — |
| SECONDARY Differences in BUN/Creatinine Measurements |
-4; 1.67; 0.095; .04 | — |
| SECONDARY Change in LV Size |
-.125; -1.4 | — |
| SECONDARY Number of Procedure-related Adverse Events |
3; 3 | — |
| SECONDARY Changes in Mean Arterial Pressure |
3.33; 13.77 | — |
| SECONDARY Number of Participants With Orthostatic Hypertension |
0; 0 | — |
| SECONDARY Number of Participants With Other Complications |
1; 2 | — |
| SECONDARY Number of Occurrences of Major Complication Rate |
2; 3 | — |
| SECONDARY Procedure Time |
27.83 | — |
Summary
Despite significant advances in the management of ventricular arrhythmias through the use of ICD therapy, AADs, and catheter-based ablation strategies, considerable challenges remain. The optimal method for the prevention of recurrent VT following catheter ablation remains unclear. RSDN may be an effective tool for preventing ventricular arrhythmias, and associated ICD therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. Although RSDN has been shown to reduce the recurrence of VT in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of RSDN in the prevention of recurrent VT in patients following catheter ablation of VT with ischemic or non-ischemic ventricular dysfunction. This study will specifically evaluate the safety and efficacy of adjunctive RSDN in the prevention of ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based VT ablation.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age
- Structural heart disease (post-MI, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.)
- Planned for catheter-based ablation of VT
- All patients will have an existing ICD
- 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
- MI or CVA within 30 days
- Coronary Artery Bypass Graft (CABG) within 30 days of this procedure
- Known renovascular abnormalities that would preclude RSDN (eg, renal artery stenosis)
- GFR <30 ml/min (unless receiving dialysis)
- Life expectancy <1 year for any medical condition
- Any condition resulting in a contraindication to anticoagulation (e.g. GI bleeding)
- Inability to give informed consent
- Known pregnancy or positive -HCG within 7 days of procedure.
Data sourced from ClinicalTrials.gov (NCT01858194). 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.