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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02646501
Enrollment
20
Registered
2016-01-05
Start date
2019-03-31
Completion date
2019-09-30
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Ventricular Tachycardia

Brief 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.

Detailed 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.

Interventions

Antiarrhythmic drug

percutaneous stellate ganglion block (PSGB)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of VT/VF episodes after randomization5 days after randomization
Duration of VT/VF episodes after randomization5 days after randomization

Secondary

MeasureTime frameDescription
mortality1 month after the enrollmentdeath, cause of death,
procedure related complication1 month after the enrollment

Countries

South Korea

Contacts

Primary ContactHui-Nam Park, MD, Ph.D
hnpak@yuhs.ac82-2-2228-8459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026