Refractory Ventricular TachycardiaNCT02646501
Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia
A study testing Antiarrhythmic drug and percutaneous stellate ganglion block (PSGB) in people with Refractory Ventricular Tachycardia, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Refractory Ventricular Tachycardia
- What is being tested?
- Antiarrhythmic drug and percutaneous stellate ganglion block (PSGB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2019to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
Hui-Nam Pak, M.D., Ph.D., 82-2-2228-8459, hnpak@yuhs.ac
About this study
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.
Read the 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.
- Conditions
- Refractory Ventricular Tachycardia
- Being tested
- Antiarrhythmic drug, percutaneous stellate ganglion block (PSGB)
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrhythmic drugDrug
Antiarrhythmic drug
percutaneous stellate ganglion block (PSGB)Procedure or surgery
percutaneous stellate ganglion block (PSGB)
| Study group | Role | What they receive |
|---|---|---|
| group A+PSGB | Experimental | (Antiarrhythmic drug + percutaneous stellate ganglion block) group Receives: Drug: Antiarrhythmic drug; Procedure: percutaneous stellate ganglion block (PSGB) |
| group A | Active comparator | Antiarrhythmic drug group Receives: Drug: Antiarrhythmic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of VT/VF episodes after randomization
Measured: 5 days after randomization
Duration of VT/VF episodes after randomization
Measured: 5 days after randomization
Secondary outcomes (2)
mortality
death, cause of death,
Measured: 1 month after the enrollment
procedure related complication
Measured: 1 month after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMar 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646501
- Sponsor's protocol ID
- 4-2015-0743
- Status last verified
- Feb 2019
- First submitted
- 4 Jan 2016
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial for Effect of Stellate Ganglion Block in Medically Refractory Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT02646501
- Acronym / sponsor ID
- 4-2015-0743
- Conditions
- Refractory Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A+PSGB | Experimental | Drug: Antiarrhythmic drug, Procedure: percutaneous stellate ganglion block (PSGB)(Antiarrhythmic drug + percutaneous stellate ganglion block) group |
| group A | Active comparator | Drug: Antiarrhythmic drugAntiarrhythmic drug group |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiarrhythmic drugAntiarrhythmic drug | Drug | group A, group A+PSGB |
| percutaneous stellate ganglion block (PSGB)percutaneous stellate ganglion block (PSGB) | Procedure or surgery | group A+PSGB |
Primary outcome
Number of VT/VF episodes after randomization
Time frame: 5 days after randomization
Duration of VT/VF episodes after randomization
Time frame: 5 days after randomization
2 secondary outcomes
mortality
Time frame: 1 month after the enrollment
procedure related complication
Time frame: 1 month after the enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
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Cardiac Radioablation for VT
Ventricular Tachycardia, Myocardial Infarction
Recruiting
Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiarrhythmic drug and percutaneous stellate ganglion block (PSGB) in people with Refractory Ventricular Tachycardia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Nam Park, MD, Ph.D (82-2-2228-8459, hnpak@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of VT/VF episodes after randomization (time frame: 5 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.