REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

Ventricular Tachycardia Clinical Trial

— RESET-VT  

Official title:

REnal Sympathetic dEnervaTion as an a Adjunct to Catheter-based VT Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858194
• Other study ID #: GCO 13-1462
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 1, 2017

Study information

• Verified date: April 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Renal sympathetic denervation
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).
• VT ablation alone
Placebo arm will receive standard VT ablation using current techniques

Locations

Country	Name	City	State
Czechia	Homolka Hospital	Prague
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vivek Reddy

Countries where clinical trial is conducted

United States,  Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From First Event Requiring ICD Therapy	Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months	24 months
Secondary	Number of Appropriate ICD Shocks for Ventricular Arrhythmia	An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.	at 24 months
Secondary	Number of Inappropriate ICD Therapy	Number of inappropriate ICD therapy including both appropriate and inappropriate shocks	at 24 months
Secondary	All ICD Therapies (Appropriate + Inappropriate)	cumulative ICD therapies including both appropriate and inappropriate shocks	24 months
Secondary	Number of Participants With Mortality, ICD Storm and Incessant VT	Number of Participants with a composite of Mortality, ICD storm, and Incessant VT	24 months
Secondary	Number of Participants With Hospitalizations for Cardiovascular Causes		24 months
Secondary	Number of Episodes of Total VT Burden	Total VT burden (Number of episodes)	at 24 months
Secondary	Number of Participants With All-Cause Mortality		24 months
Secondary	Number of Participants With Occurrences of ICD Storm	The occurrence of ICD storm, defined as =3 appropriate shock therapies within 24 hours.	24 months
Secondary	Change in Brain Natriuretic Peptide (BNP)	Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.	at baseline and at 12 months
Secondary	Differences in BUN/Creatinine Measurements	Differences in BUN/creatinine measurements compared at 12 months to baseline.	baseline and 12 months
Secondary	Change in LV Size	LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline	baseline and 12 months
Secondary	Number of Procedure-related Adverse Events	Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction.	24 months
Secondary	Changes in Mean Arterial Pressure	Change in mean arterial pressure	baseline and 24 months
Secondary	Number of Participants With Orthostatic Hypertension	Number of participants with other individual complication rates specifically orthostatic hypertension	24 months
Secondary	Number of Participants With Other Complications	Other individual complication rates including, but not limited to MI and death	at 24 months
Secondary	Number of Occurrences of Major Complication Rate	30-day Major Complication Rate defined as death, stroke, MI or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer)	30 days
Secondary	Procedure Time	Renal Denervation Procedure time	during procedure