Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias
Renal Nerve Stimulation and Renal Denervation in Patients With Sympathetic Ventricular Arrhythmias
Rationale:

 Sympathetic activity plays an important role in the pathogenesis of ventricular
 tachyarrhythmia. Previous studies have shown evidence of significant heritable influences on
 individual responses to adrenergic stimulation. Catheter-based renal sympathetic denervation
 (RDN) is a novel treatment option for patients with resistant hypertension, proved to reduce
 local and whole-body sympathetic activity. The investigators hypothesize that percutaneous
 transluminal electrical stimulation of the sympathetic nerve bundles in the renal arteries
 will cause ventricular arrhythmias and renal denervation will suppress these arrhythmias in
 patients with sympathetic ventricular arrhythmias.

 Objective:

 This study will investigate the effects of renal nerve stimulation before and after
 percutaneous transluminal RDN on cardiac excitable properties including induction of
 ventricular tachy-arrhythmias before and after RDN in six studies, i.e. patients with
 catecholaminergic polymorphic ventricular tachycardia (CPVT), long QT syndrome and
 arrhythmogenic right ventricular cardiomyopathy (ARVC), sympathetically driven ventricular
 arrhythmias, hypertrophic cardiomyopathy (HCM), dilated non-ischemic cardiomyopathy (DCM) and
 ischemic cardiomyopathy (ICM). The aim of the six studies is to assess the anti-arrhythmic
 effects of RDN in patients with sympathetic ventricular tachy-arrhythmias.

 Study design:

 Investigator initiated, multi centre, six pretest-posttest design studies.

 Study population:

 Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal
 pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT
 syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-85
 year.

 Intervention:

 RDN will be performed according to routine clinical practice. Prior to the ablation
 procedure, catheter mapping of the renal arteries will be performed according to routine
 clinical practice. Clinical and biological responses to transluminal electrical renal nerve
 stimulation will be assessed before and after RDN.

 Study endpoints:

 -  Main procedural study endpoint: Induction of ventricular arrhythmias in response to
 renal nerve stimulation prior to RDN and absence of renal nerves stimulation induced
 ventricular arrhythmias after RDN.

 -  Main clinical study endpoint: Development of ventricular arrhythmia during exercise
 stress testing performed 6 months after procedure.

 Nature and extent of the burden and risks associated with participation, benefit and group
 relatedness:

 In several studies, it was shown that RDN was safe. The intervention resulted in
 significantly better control of blood pressure with less medication, and beneficial changes
 in heart rate variability, autonomic sympathetic balance, renal arteriolar function, and a
 higher success of atrial fibrillation prevention. In case reports and case series, RDN had a
 favourable effect in patients with sympathetic drug refractory ventricular tachy-arrhythmias.
Inclusion Criteria:

 1. The patient is willing and able to comply with the protocol and has provided written
 informed consent.

 2. The patient falls within the target group as stated in 4.1.

 3. Patient is an acceptable candidate for RDN treatment

 4. Patient is 18-85 years of age

 5. Documentation of ventricular arrhythmia (ECG, rhythm strip or ICD interrogation)

 Exclusion Criteria:

 1. Contraindication to anticoagulation therapy or heparin.

 2. Previous selective cardiac sympathetic denervation or previous RDN procedure.

 3. Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to
 enrolment.

 4. Untreated hypothyroidism or hyperthyroidism.

 5. More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate
 or severe).

 6. Severe LV dysfunction (LVEF <20% and/or grade 3/4 diastolic dysfunction).

 7. Enrolment in another investigational drug or device study.

 8. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures
 during fertile age.

 9. Mental or physical inability to participate in the study.

 10. Planned cardiovascular intervention.

 11. Life expectancy ≤ 12 months.

 12. Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ≤3 mm.

 13. Complex renal artery