Patients with CPVT or certain types of long QT syndrome or ARVC.
Conditions
Interventions
Renal artery mapping and renal denervation:
A. Catheter mapping of renal arteries and the renal sympathetic nerve distribution with fluoroscopic and nonfluoroscopic 3D navigation systems (Philips EP N
Sponsors
Isala, Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: Patients with recurrent sympathetically driven ventricular arrhythmia despite optimal pharmacological therapy. Patients should be diagnosed with CPVT and certain types of long QT syndrome, ARVC, HCM, DCM and ICM. Eligible patients will be in the age category of 18-85 year.
Exclusion criteria
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 enrollment Untreated hypothyroidism or hyperthyroidism. More than grade 1/3 valvular regurgitation and/or signifant valve stenosis. Severe LV dysfunction. Planned cardiovascular intervention. Renal artery stenosis >50% of the arterial lumen, or renal artery lumen< 3 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Main procedural study endpoint will be: Induction of ventricular arrhythmias in response to renal nerve stimulation prior to renal denervation and absence of renal nerves stimulation induced ventricular arrhythmias after renal denervation. -Main clinical study endpoint will be: development of ventricular arrhythmia during exercise stress testing performed 6 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first detection of ventricular arrhythmia or appropriate ICD therapy with the monitoring period starting immediately after the intervention. 2. Changes in ventricular refractoriness and inducibility of ventricular arrhythmias to programmed electrical stimulation in the setting of routine electrophysiological study before and after renal denervation. 3. Ventricular arrhythmia burden after 6 and 12 months of follow-up in patients with ICD or continuous rhythm monitoring with a loop recorder. The monitoring period starts immediately after the intervention in the RDN group and after randomization in the control group. 4. Blood pressure at 6 and 12 months after the intervention, and change in blood pressure compared to measurement before the intervention 5. (Supra-)Ventricular arrhythmias, heart rate and blood pressure response changes induced by exercise testing Changes in heart rate variability measures tested by Holter monitoring compared to measurement before the intervention. | — |
Contacts
Public ContactSonja Postma
Dokter Stolteweg 96
Outcome results
None listed