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

NCT ID: NCT02071511

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

Ablation of ventricular arrhythmias

Group Type: ACTIVE_COMPARATOR

Ablation of ventricular arrhythmias

Intervention Type: PROCEDURE

control group: Ablation of ventricular arrhythmias

intervention group

Ablation of ventricular arrhythmias + renal denervation

Group Type: SHAM_COMPARATOR

Ablation of ventricular arrhythmias + renal denervation

Intervention Type: PROCEDURE

Intervention group: Ablation of ventricular arrhythmias + renal denervation

Interventions

Ablation of ventricular arrhythmias

control group: Ablation of ventricular arrhythmias

Intervention Type: PROCEDURE

Ablation of ventricular arrhythmias + renal denervation

Intervention group: Ablation of ventricular arrhythmias + renal denervation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Willems, MD

Role: PRINCIPAL_INVESTIGATOR

ASKLEPIOS St. Georg

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

PV4286

Identifier Type: -

Identifier Source: org_study_id