Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
Study hypothesis:

 With optimal medical therapy and repeated ablations, an additional renal denervation may have
 protective effects in terms of vegetative intrinsic activity and lead to a significant
 reduction in VT Burdens.

 Study design:

 Multicenter, randomized, prospective, single-blind clinical trial.
Study protocol:

 Catheter ablation of ventricular tachycardia versus combined catheter ablation of ventricular
 tachycardia and renal denervation.

 A total of 50 patients with ventricular tachycardia treated with ICD shocks or ATP will be
 enrolled in this study. The randomization in the study is done before ablation.

 For the ablation, an arterial access is required in both groups. During a 30 minutes waiting
 time which will apply to both groups, renal denervation will be performed.

 In this period of time operators and staff will be blinded for the procedure, thereby they
 won't know if the patients will receive a renal denervation, in that way the investigators
 are avoiding a bias of future treatment of the patients.

 Follow up and repeat procedures:

 All Patients will be followed for a period of 3, 6, 9, 12 and 18 months after the procedure.

 Regular visits are done in the investigators office. The visit will include ICD
 Interrogation, VT documentation in ICD Holter, 24-hour Holter ECG or Tele-ECGs,
 echocardiography.

 Re- VT ablations are allowed at any time. In case of renal artery stenosis, denervation will
 not be performed. Drug therapy can be continued.
Inclusion Criteria:

 -  Age ≥ 18 years

 -  Ischemic cardiomyopathy

 -  NYHA II-III

 -  Recurrent ventricular tachycardia, ICD interventions (shock or ATP)

 -  Obtained written informed consent

 Exclusion Criteria:

 -  Age <18 years

 -  Previous VT ablation

 -  NYHA IV

 -  Cardiopulmonary decompensation within the last 4 weeks

 -  Pregnant women or women of childbearing potential without a negative pregnancy test
 within 48 hours prior to treatment

 -  History of hemorrhagic diathesis or other coagulopathies

 -  Contraindication for oral anticoagulation

 -  Hyper- or hypothyroidism

 -  Drug or chronic alcohol abuse

 -  Has any condition that would make participation not be in the best interest of the
 subject

 -  Incompliance