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

Vivek Reddy

Status

Completed

Conditions

Ventricular Tachycardia

Treatments

Device: VT ablation alone

Device: Renal sympathetic denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT01858194

GCO 13-1462

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.