Clinical trial NCT01858194: REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Official title: REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Tachycardia, Renal Sympathetic Denervation
Catheter Ablation
Cardioverter-Defibrillator
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The goal of this trial is to test the impact of catheter-based renal sympathetic denervation (RSDN) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (VT). The proposed study is a prospective, multicenter, randomized control trial. Patients undergoing VT ablation will be randomized to either VT ablation alone or VT ablation + RSDN.

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.

Primary outcomes:
measure: Freedom From First Event Requiring ICD Therapy
timeFrame: 24 months
Secondary outcomes:
measure: Number of Appropriate ICD Shocks for Ventricular Arrhythmia
timeFrame: at 24 months
measure: Number of Inappropriate ICD Therapy
timeFrame: at 24 months
measure: All ICD Therapies (Appropriate + Inappropriate)
timeFrame: 24 months
measure: Number of Participants With Mortality, ICD Storm and Incessant VT
timeFrame: 24 months
measure: Number of Participants With Hospitalizations for Cardiovascular Causes
timeFrame: 24 months
measure: Number of Episodes of Total VT Burden
timeFrame: at 24 months
measure: Number of Participants With All-Cause Mortality
timeFrame: 24 months
measure: Number of Participants With Occurrences of ICD Storm
timeFrame: 24 months
measure: Change in Brain Natriuretic Peptide (BNP)
timeFrame: at baseline and at 12 months
measure: Differences in BUN/Creatinine Measurements
timeFrame: baseline and 12 months
measure: Change in LV Size
timeFrame: baseline and 12 months
measure: Number of Procedure-related Adverse Events
timeFrame: 24 months
measure: Changes in Mean Arterial Pressure
timeFrame: baseline and 24 months
measure: Number of Participants With Orthostatic Hypertension
timeFrame: 24 months
measure: Number of Participants With Other Complications
timeFrame: at 24 months
measure: Number of Occurrences of Major Complication Rate
timeFrame: 30 days
measure: Procedure Time
timeFrame: during procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Prague
country: Czechia
facility: Homolka Hospital
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Y Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: