Clinical trial NCT02071511: Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
Official title: Renal Denervation In Patient Undergoing VT Ablation:Combined Renal Denervation and VT Ablation vs. Simply VT Ablation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventricular Tachycardia
Cardiomyopathy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-02-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients with adverse events such as recurrens of Ventricular Tachycardias or necessary Intracardiac shocks during 24 months follow up
timeFrame: 24 months
Secondary outcomes:
measure: Number of Patients with Ventricular extrasystoles and non-sustained Ventricular Tachycardias compared to the time prior to ablation during 24 months follow up
timeFrame: 24 months
measure: Number of periprocedural complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: ASKLEPIOS St. Georg
name: Stephan Willems, MD
role: PRINCIPAL_INVESTIGATOR
References: