Renal Nerve Stimulation and Renal Denervation in Patients with Sympathetic Ventricular Arrhythmias

Phase 2

Completed

Conditions: central autonomic nervous system
Sympathetic ventricular tachy-arrhythmias
10007521

Registration Number: NL-OMON44978

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Patients with recurrent sympathetic ventricular arrhythmia despite optimal pharmacological therapy.
Patients with CPVT or certain types of long QT syndrome, ARVC, HCM, DCM or ICM. Patients should use adequate beta-blocker dose or should be intolerant for anti-arrhythmic medication.
Patient is an acceptable candidate for renal denervation treatment
Patient is 18-85 years of age
Documentation of ventricular arrhythmia (ECG, rhythm strip or ICD interrogation)

Exclusion Criteria

Contraindication to anticoagulation therapy or heparin.
Previous selective cardiac sympathetic denervation or previous renal denervation procedure.
Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to enrolment.
Untreated hypothyroidism or hyperthyroidism.
More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe).
Severe LV dysfunction (LVEF <20% and/or grade 3/4 diastolic dysfunction)
Planned cardiovascular intervention.
Renal artery stenosis >50% of the arterial lumen, or renal artery lumen <=3 mm.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Induction of ventricular arrhythmias in response to renal nerve stimulation<br /><br>prior to renal denervation and absence of ventricular arrhythmias in response<br /><br>to renal nerves stimulation after renal denervation.<br /><br>Induction of ventricular arrhythmia during exercise stress testing performed 6<br /><br>months after renal denervation.</p><br>

Secondary Outcome Measures