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

Ventricular Tachycardia Clinical Trial

— ARDEVAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02071511
• Other study ID #: PV4286
• Status: Terminated
• Phase: N/A
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• Ablation of ventricular arrhythmias
control group: Ablation of ventricular arrhythmias
• Ablation of ventricular arrhythmias + renal denervation
Intervention group: Ablation of ventricular arrhythmias + renal denervation

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up	Number of Patients with adverse events such as recurrens of Ventricular	24 months
Secondary	Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up	Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up	24 months
Secondary	Number of periprocedural complications	Number of periprocedural complications	24 months