Overview

This trial is active, not recruiting.

Condition ventricular tachycardia
Treatments renal sympathetic denervation, vt ablation alone
Sponsor Vivek Reddy
Start date March 2013
End date March 2017
Trial size 202 participants
Trial identifier NCT01858194, B 12-02-395-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Catheter-based Renal Sympathetic Denervation Ablation Arm
renal sympathetic denervation Ablation Arm
The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation. After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a "spiral pattern", see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion).
(Placebo Comparator)
No further therapy in addition to VT ablation
vt ablation alone
Placebo arm will receive standard VT ablation using current techniques

Primary Outcomes

Measure
Time to first event requiring appropriate ICD therapy or Incessant VT
time frame: at 1 month
Time to first event requiring appropriate ICD therapy or Incessant VT
time frame: at 6 months
Time to first event requiring appropriate ICD therapy or Incessant VT
time frame: at 12 months
Time to first event requiring appropriate ICD therapy or Incessant VT
time frame: at 18 months
Time to first event requiring appropriate ICD therapy or Incessant VT
time frame: at 24 months

Secondary Outcomes

Measure
Appropriate ICD therapy for ventricular arrhythmia
time frame: at 1 month
Appropriate ICD therapy for ventricular arrhythmia
time frame: at 6 months
Appropriate ICD therapy for ventricular arrhythmia
time frame: at 12 months
Appropriate ICD therapy for ventricular arrhythmia
time frame: at 18 months
Appropriate ICD therapy for ventricular arrhythmia
time frame: at 24 months
Cumulative ICD therapies
time frame: at 24 months
Cumulative ICD therapies
time frame: at 6 months
Cumulative ICD therapies
time frame: at 12 months
Cumulative ICD therapies
time frame: at 18 months
VT occurring below the ICD rate cut-off
time frame: at 1 month
VT occurring below the ICD rate cut-off
time frame: at 6 months
VT occurring below the ICD rate cut-off
time frame: at 12 months
VT occurring below the ICD rate cut-off
time frame: at 18 months
VT occurring below the ICD rate cut-off
time frame: at 24 months
Number of Hospitalizations for Cardiovascular Causes
time frame: at 1 month
Number of Hospitalizations for Cardiovascular Causes
time frame: at 6 months
Number of Hospitalizations for Cardiovascular Causes
time frame: at 12 months
Number of Hospitalizations for Cardiovascular Causes
time frame: at 18 months
Number of Hospitalizations for Cardiovascular Causes
time frame: at 24 months
Total VT burden
time frame: at 1 month
Total VT burden
time frame: at 6 months
Total VT burden
time frame: at 12 months
Total VT burden
time frame: at 18 months
Total VT burden
time frame: at 24 months
All-Cause Mortality
time frame: at 1 month
All-Cause Mortality
time frame: at 6 months
All-Cause Mortality
time frame: at 12 months
All-Cause Mortality
time frame: at 18 months
All-Cause Mortality
time frame: at 24 months
occurrence of ICD storm
time frame: at 1 month
occurrence of ICD storm
time frame: at 6 months
occurrence of ICD storm
time frame: at 12 months
occurrence of ICD storm
time frame: at 18 months
occurrence of ICD storm
time frame: at 24 months
Differences in blood hormone measurements
time frame: at baseline and at 12 months
Differences in BUN/creatinine measurements
time frame: baseline and 12 months
Differences in cardiac parameters
time frame: baseline and 12 months
adverse events
time frame: participants will be monitored following the procedure for the duration of the hospital stay, on average, an expected 24 hour period.
adverse events
time frame: at 1 month
adverse events
time frame: at 6 months
adverse events
time frame: at 12 months
adverse events
time frame: at 18 months
adverse events
time frame: at 24 months
Changes in blood pressure
time frame: at 1 month
Changes in blood pressure
time frame: at 6 months
Changes in blood pressure
time frame: at 12 months
Changes in blood pressure
time frame: at 18 months
Changes in blood pressure
time frame: at 24 months
Other Complications
time frame: at 1 month
Other Complications
time frame: at 6 months
Other Complications
time frame: at 12 months
Other Complications
time frame: at 18 months
Other Complications
time frame: at 24 months
Major Complication Rate
time frame: up to 12 months
Procedure time
time frame: during procedure

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation
Principal investigator Vivek Y Reddy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai.