REnal SympathetiC Denervation to sUpprEss Tachyarrhythmias in ICD Recipients
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      The objective of this trial is to determine the efficacy and safety of adjunctive
      catheter-based renal sympathetic denervation (RSDN) in the primary prevention of implantable
      cardioverter defibrillator (ICD) therapy in patients with ischemic or non-ischemic
      ventricular dysfunction, who are to receive an ICD for either i) secondary prevention, or ii)
      primary prevention + inducible ventricular tachycardia (VT) by programmed ventricular
      stimulation at the time of ICD implantation. These patients will be randomized to ICD alone
      or ICD + RSDN.
    

Detailed description: 
      Rationale for this Study

      Despite significant advances in the management of ventricular arrhythmias through the use of
      ICD therapy, anti-arrhythmic drugs (AADs), and catheter-based ablation strategies,
      considerable challenges remain. The optimal method for the prevention of ICD shocks 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. 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 primary prevention of
      ICD therapy in patients with ischemic or non-ischemic ventricular dysfunction. Also of note,
      there is data suggesting that RSDN may even decrease the rate of supraventricular arrhythmias
      such as atrial fibrillation. Thus, RESCUE will specifically evaluate the safety and efficacy
      of RSDN in the prevention of ICD therapy in patients with ventricular dysfunction who are to
      receive an ICD for either secondary prevention, or primary prevention if they have inducible
      VT by programmed ventricular stimulation at the time of ICD implantation.

      Description of Procedures

      Screening:

      To take part in this study, you must meet all study requirements. The screening visit tests
      and procedures are done to see if you are eligible to be in the study. The study doctor will
      review these with you and let you know if you qualify. The study doctor will make a final
      decision about your possible study qualification.

      Pre-randomization Procedures:

      After providing written consent the following data will be collected and examinations and
      tests performed:

        -  A physical examination

        -  Your blood pressure will be taken

        -  A review of your medical history and what medications you are taking

        -  A blood sample will be drawn for routine laboratory tests.

        -  Women who can have children will take a urine pregnancy test. The test must be negative
           for you to be in this study.

        -  A Transthoracic Echocardiogram (TTE)-a non-invasive test where a probe is placed on the
           chest wall and images are taken through the chest wall of the heart valves and heart
           muscle, that will measure the left ventricular size (heart wall thickness) and mitral
           inflow (flow of blood through the heart valve).

        -  An ICD interrogation (if you already have an ICD implanted) - a non-invasive test where
           a device is placed over the chest wall near your ICD, and data is transmitted wirelessly
           from your ICD to a laptop for your physician to review.

        -  An electrocardiogram (EKG) - a non-invasive test where several probes are placed on the
           chest wall that will measure electrical activity in your heart.

      Randomization:

      Immediately following the catheter ablation, patients will undergo a renal angiogram in order
      to assess suitability for catheter-based renal sympathetic denervation. A renal angiogram is
      an x-ray study of the blood vessels in the kidney to evaluate for blockage, and abnormalities
      that could be affecting the blood supply to the kidney. It is performed by injecting contrast
      dye through a catheter (a tiny tube) into the blood vessels of the kidney. The study doctor
      will assess whether the renal arteries are suitable to receive catheter-based renal
      denervation. Once you agree to participate in this study, by signing this informed consent,
      and are it is determined that you are eligible to participate you will be randomized to one
      of two treatment groups immediately following the renal angiogram.

      Randomization means that you are put into a group by chance. It is like flipping a coin. You
      will have an equal chance (50%) of being placed in either group. This study design is
      single-blinded; you will not know ahead of time which group you will be in. Only your
      physician will know which group you are randomized to.

      If you do not already have an ICD, you will undergo ICD placement as part of routine clinical
      care. You may undergo ICD placement up to 1 month (30 days) before randomization. An ICD
      (implantable cardioverter-defibrillator) is a small battery-powered electrical impulse
      generator which is implanted in patients who are at risk of sudden cardiac death due to
      ventricular fibrillation and ventricular tachycardia. The device is programmed to detect
      abnormal heart beats (cardiac arrhythmia) and correct it by delivering a jolt of electricity.

      The first group will undergo catheter-based sympathetic renal denervation. Renal Sympathetic
      Denervation is a procedure that uses a catheter probe inserted into the renal (kidney) artery
      that deactivates the nerves that are linked to high blood pressure.

      The second group (control group) will receive no further intervention after ICD implantation.
    

Intervention name(s): Boston Scientific Vessix Renal Denervation System
Intervention type(s): Device
Intervention description(s): Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts
Other intervention name(s): Renal sympathetic denervation; Renal denervation; Denervation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Renal sympathetic denervation; Renal catheter ablation; Ventricular tachycardia