NCT02071511

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ventricular Tachycardia
• Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	Ablation of ventricular arrhythmias	control group: Ablation of ventricular arrhythmias
PROCEDURE	Ablation of ventricular arrhythmias + renal denervation	Intervention group: Ablation of ventricular arrhythmias + renal denervation

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2016-08-01
• First posted: 2014-02-26
• Last updated: 2022-09-21

Locations

1 site across 1 country: Germany