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

Refractory Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02646501
• Other study ID #: 4-2015-0743
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: September 2019

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: Hui-Nam Park, MD, Ph.D
• Phone: 82-2-2228-8459
• Email: hnpak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractory Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Drug:
• Antiarrhythmic drug
Antiarrhythmic drug

Procedure:
• percutaneous stellate ganglion block (PSGB)
percutaneous stellate ganglion block (PSGB)

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of VT/VF episodes after randomization		5 days after randomization
Primary	Duration of VT/VF episodes after randomization		5 days after randomization
Secondary	mortality	death, cause of death,	1 month after the enrollment
Secondary	procedure related complication		1 month after the enrollment