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

Universitätsklinikum Hamburg-Eppendorf

Status: Terminated

Conditions: Cardiomyopathy; Ventricular Tachycardia

Treatments: Procedure: Ablation of ventricular arrhythmias; Procedure: Ablation of ventricular arrhythmias + renal denervation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02071511

PV4286

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

control group

Active Comparator group

Description:

Ablation of ventricular arrhythmias

Treatment:

Procedure: Ablation of ventricular arrhythmias

intervention group

Sham Comparator group

Description:

Ablation of ventricular arrhythmias + renal denervation

Treatment:

Procedure: Ablation of ventricular arrhythmias + renal denervation