Ventricular ArrythmiaPhase 3GANGSTERNCT05078684
GANGlion Stellate Block for Treatment of Electric storRm (GANGSTER Trial)
A Phase 3 study testing Left ganglion stellate block in people with Ventricular Arrythmia and Ventricular Tachycardia, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- Left ganglion stellate block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 21 Aug 2021to 31 Jan 2025
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- arrhythmic storm <24 hours before inclusion:
- 3 or more episodes of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) terminated by external or internal shock,
- or incessant VT lasting >30 minutes,
- or very frequent nonsustained or sustained VT leading to hemodynamic instability with the need of escalation of the therapy
- clinical indication for LBGS based on the judgment of the physician, independent of the study
Who cannot join
- known allergy to bupivacaine
- prior LBGS performed <7 days before the study
- known reversible provoking trigger of the arrhythmias
- ventricular arrhythmias triggered by premature ectopic beats during bradycardia
- hemodynamically tolerated idiopathic VT in patients without structural heart disease
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague, 14059
Marek Sramko, MD, PhD, +420731682681, marek.sramko@ikem.cz
About this study
Official title: Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study
This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.
Read the detailed description
- The study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (LGSB) before or after catheter ablation.
- Included participants will be dived based on the need for mechanical ventilation and catheter ablation performed <5 days before the study
- Subsequently, the participants will be randomized to LGSB or to a sham (placebo) procedure.
- The primary endpoint will be a reduction of the burden of clinical arrhythmia >50% 24 hours after LGSB without escalation of antiarrhythmic therapy.
- The study will include 80 patients over 4 years.
- Conditions
- Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation, Arrhythmic Storm, Block
- Being tested
- Left ganglion stellate block, Sham left ganglion stellate block
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left ganglion stellate blockProcedure or surgery
Ultrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine.
Sham left ganglion stellate blockProcedure or surgery
Subcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB
| Study group | Role | What they receive |
|---|---|---|
| Actual LGSB | Active comparator | The patients will receive an actual LGSB procedure:
Using ultrasound navigation and an echo-contrast needle, 8ml of bupivacain (5%) will be applied to the site of the left ganglion stellate through an anterolateral approach in the neck region. Receives: Procedure: Left ganglion stellate block |
| Sham procedure | Sham comparator | The procedure will be performed using the same instruments and anesthetic drug as the actual LGSB. However, the operator will apply only 0.5-1ml of the anesthetic drug and only subcutaneously to the site where an actual LGSB would be performed. Receives: Procedure: Sham left ganglion stellate block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of episodes of sustained VT/VF
Change by >50% of the number of episodes of sustained ventricular tachycardia/fibrillation compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation)
Measured: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Change in arrhythmia burden quantified by Holter ECG
Change of the percent of QRS complexes with ventricular tachycardia by >50% on Holter ECG, as compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation).
Measured: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start21 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1 for active treatment vs. sham procedure
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marek Sramko, MD, PhD, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078684
- Sponsor's protocol ID
- A-21-25
- Acronym
- GANGSTER
- Status last verified
- Oct 2021
- First submitted
- 21 Aug 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganglion Stellate Block for Treatment of Electric Storm - a Randomized Study
- ClinicalTrials.gov ID
- NCT05078684
- Acronym / sponsor ID
- GANGSTER / A-21-25
- Conditions
- Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation, Arrhythmic Storm, Block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 14 Oct 2021 (actual)
- 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.
This study will evaluate the acute effect of ultrasound-navigated left ganglion stellate block to suppress ventricular arrhythmia in patients with arrhythmic storm.
Detailed description
- The study will include patients with drug-refractory arrhythmic storm indicated for left ganglion stellate block (LGSB) before or after catheter ablation.
- Included participants will be dived based on the need for mechanical ventilation and catheter ablation performed <5 days before the study
- Subsequently, the participants will be randomized to LGSB or to a sham (placebo) procedure.
- The primary endpoint will be a reduction of the burden of clinical arrhythmia >50% 24 hours after LGSB without escalation of antiarrhythmic therapy.
- The study will include 80 patients over 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization 1:1 for active treatment vs. sham procedure
| Arm | Type | Receives |
|---|---|---|
| Actual LGSB | Active comparator | Procedure: Left ganglion stellate blockThe patients will receive an actual LGSB procedure: Using ultrasound navigation and an echo-contrast needle, 8ml of bupivacain (5%) will be applied to the site of the left ganglion stellate through an anterolateral approach in the neck region. |
| Sham procedure | Sham comparator | Procedure: Sham left ganglion stellate blockThe procedure will be performed using the same instruments and anesthetic drug as the actual LGSB. However, the operator will apply only 0.5-1ml of the anesthetic drug and only subcutaneously to the site where an actual LGSB would be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- arrhythmic storm <24 hours before inclusion:
- clinical indication for LBGS based on the judgment of the physician, independent of the study
Key exclusion criteria (5 listed)
- known allergy to bupivacaine
- prior LBGS performed <7 days before the study
- known reversible provoking trigger of the arrhythmias
- ventricular arrhythmias triggered by premature ectopic beats during bradycardia
- hemodynamically tolerated idiopathic VT in patients without structural heart 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 |
|---|---|---|
| Left ganglion stellate blockUltrasound-guided anesthetic block of left ganglion stellate using 8ml of 5% bupivacaine. | Procedure or surgery | Actual LGSB |
| Sham left ganglion stellate blockSubcutaneous application of 0.5-1ml of 5% bupivacaine to the site of expected LGSB | Procedure or surgery | Sham procedure |
Primary outcome
Change in the number of episodes of sustained VT/VF
Time frame: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Change by >50% of the number of episodes of sustained ventricular tachycardia/fibrillation compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation)
Change in arrhythmia burden quantified by Holter ECG
Time frame: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)
Change of the percent of QRS complexes with ventricular tachycardia by >50% on Holter ECG, as compared to 24 hours before LGSB, without escalation of antiarrhythmic therapy during 24 hours after LGSB (deep sedation requiring mechanical ventilation, addition of another antiarrhythmic drug, implantation of mechanical circulatory support, unplanned emergent catheter ablation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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 Phase 3 study testing Left ganglion stellate block in people with Ventricular Arrythmia and Ventricular Tachycardia, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 19 Oct 2021. 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 Czechia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marek Sramko, MD, PhD (+420776246127, marek.sramko@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of episodes of sustained VT/VF (time frame: 2-24 hours after LGSB. The first 2 hours after the LGSB will not be considered in the evaluation (i.e., blanking period)). 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 19 Oct 2021.