Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia

Yonsei University

Status: Unknown

Conditions: Refractory Ventricular Tachycardia

Treatments: Drug: Antiarrhythmic drug; Procedure: percutaneous stellate ganglion block (PSGB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02646501

4-2015-0743

Details and patient eligibility

About

The investigators will compare the effects of PSGB(percutaneous stellate ganglion block) in patients with recurrent sustained VT/VF in spite of appropriate medical therapy and cardio-version/ defibrillation after correction of underlying correctable factors with those without PSGB by prospective randomized trail. PSGB will be performed every 3 days by anesthesiology specialist after cardiologist's request, until the stabilization of VT/VF. We will compare the frequency and episode number of VT/VF, procedure related complication, acute and long-term mortality.

Full description

Recurrent ventricular tachycardia(VT)/ fibrillation(VF) increases mortality, especially in patients with structural heart disease. It has been reported that cardiac sympathectomy reduces VT/VF episodes in patients with complex VT, long QT syndrome, catecholaminergic polymorphic VT, or myocarditis. However, cardiac sympathectomy operation is hard to conduct in patients with hemodynamically unstable recurrent VT/VF or electrical storm. Therefore, we hypothesized that bed-side percutaneous stellate ganglion block (PSGB) reduces VT/VF episodes and mortality in patients with repetitive VT/VF who are properly managed with optimal medical therapies.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients agreement of consent
• AF patient age 20-85
• Patient are diagnosed Refractory Ventricular tachycardia
• Patients who have generated Refractory Ventricular tachycardia despite of defibrillation and drug therapy
• Patients with ICD have generated ICD shock or anti-tachycardia pacing despite of defibrillation and drug therapy

Exclusion criteria

• Patients who do not agree with study inclusion
• Patients who do not taken stellate ganglion block due to unstable hemodynamic status
• Patients have experienced major hemorrhagic complication
• Patients of the DNR status
• Patients with malignancy tumor, major neurogenic disease or gastrointestinal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

group A+PSGB

Experimental group

Description:

(Antiarrhythmic drug + percutaneous stellate ganglion block) group

Treatment:

Procedure: percutaneous stellate ganglion block (PSGB)

Drug: Antiarrhythmic drug

group A

Active Comparator group

Description:

Antiarrhythmic drug group

Treatment:

Drug: Antiarrhythmic drug