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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Terminated

CT.gov ID

NCT02071511

Collaborator

Medtronic (Industry)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia Cardiomyopathy	Procedure: Ablation of ventricular arrhythmias Procedure: Ablation of ventricular arrhythmias + renal denervation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group Ablation of ventricular arrhythmias	Procedure: Ablation of ventricular arrhythmias control group: Ablation of ventricular arrhythmias
Sham Comparator: intervention group Ablation of ventricular arrhythmias + renal denervation	Procedure: Ablation of ventricular arrhythmias + renal denervation Intervention group: Ablation of ventricular arrhythmias + renal denervation

Arm

Intervention/Treatment

Active Comparator: control group

Ablation of ventricular arrhythmias

Procedure: Ablation of ventricular arrhythmias

control group: Ablation of ventricular arrhythmias

Sham Comparator: intervention group

Ablation of ventricular arrhythmias + renal denervation

Procedure: Ablation of ventricular arrhythmias + renal denervation

Intervention group: Ablation of ventricular arrhythmias + renal denervation

Outcome Measures

Primary Outcome Measures

Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up [24 months]
Number of Patients with adverse events such as recurrens of Ventricular

Secondary Outcome Measures

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]
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 periprocedural complications [24 months]
Number of periprocedural complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf
Medtronic

Investigators

Principal Investigator: Stephan Willems, MD, University Heart Center Hamburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT02071511

Other Study ID Numbers:

PV4286

First Posted:

Feb 26, 2014

Last Update Posted:

May 1, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Cardiomyopathies

Tachycardia

Tachycardia, Ventricular

Study Results

No Results Posted as of May 1, 2019