Electrical StormPhase 4NCT07211347
Percutaneous Blockade of the Stellate Ganglion in Electrical Storm
A Phase 4 study testing Stellate Ganglion Block in people with Electrical Storm and Stellate Ganglion Block, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
There is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm. So far, case reports and retrospective studies suggest that such a strategy should be considered in cases refractory to initial therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrical Storm, Stellate Ganglion Block, Ventricular Arrhythmia
- What is being tested?
- Stellate Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jun 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients over 18 years old with structural heart disease and a diagnosis of refractory electrical storm, or those who require discontinuation of antiarrhythmics due to adverse events or contraindications to standard therapy.
Who cannot join
- Patients under 18
- History of heart transplant or prior cardiac denervation surgery
- Anatomical contraindications for the procedure (prior neck surgery, burns, large scars, or thyroid goiter).
- Genetically related polymorphic VT
- End-stage renal disease on dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Clinical Research Center of the Heart Institute - University of São Paulo
São Paulo, São Paulo, 05409011
Alberto P Ferraz, MD, 11981043839, albertopferraz@gmail.com
albertopferraz@gmail.com
About this study
Official title: Percutaneous Blockade Protocol of the Stellate Ganglion in Patients With Refractory Electrical Storm
There is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm. So far, case reports and retrospective studies suggest that such a strategy should be considered in cases refractory to initial therapy. In this scenario, the European and American guidelines for the treatment of ventricular arrhythmias recommend autonomic modulation in this setting, but only with a level of recommendation IIb (1,2). This project aims to evaluate the effect of stellate ganglion infiltration in patients with electric storm refractory to initial clinical measures. It is a randomized clinical trial where patients will receive treatment with a lidocaine and bupivacaine anesthetic solution or no intervention. The effect of the intervention will be considered positive when there is a reduction of arrhythmic events of at least 50% in the 12 hours immediately after.
Read the detailed description
The study aims to evaluate the reduction of arrhythmic events following stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Hypothesis Stellate ganglion infiltration is an effective neuromodulation strategy for controlling arrhythmic events in patients with electrical storm awaiting definitive therapy.
Methodology This is a single-center randomized study investigating the efficacy of stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Participant Selection and Sample Size Participants will include patients admitted to the Emergency Unit or any Intensive Care Unit with a diagnosis of refractory electrical storm. Based on the STAR study, which reported a median of 6 arrhythmic events before SGB (IQR: 3 to 15.8), and aiming for at least a 50% reduction in arrhythmias in the active group post-procedure (with no expected change in the placebo group), a sample size of 32 patients per group was calculated (alpha = 0.05, power = 80%, two-tailed test).
Definitions Electrical storm (ES) is defined as three or more episodes of ventricular arrhythmias (including appropriate ICD therapies), separated by at least 5 minutes, within 24 hours. Refractory ES is defined as recurrent arrhythmias despite antiarrhythmic drug administration. Patients requiring discontinuation of antiarrhythmics due to adverse events will also be eligible for SGB. An arrhythmic event is defined as an episode of sustained VT or VF (>30 seconds or unstable), treated or not with antitachycardia pacing (ATP), electrical therapy, ICD shock, or external defibrillation. Pre-specified complications include: simple hematoma, hematoma requiring intervention, symptoms due to anesthetic absorption, brachial plexus injury, simple vascular injury, and vascular injury requiring intervention.
Randomization Randomization will be performed by a medical professional not involved in the infiltration procedure and blinded to data analysis, using the "Randomizer for Clinical Trial" software.
- Being tested
- Stellate Ganglion Block
- Keywords
- Ventricular Arrhythmia, Electrical Storm, Stellate ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
There is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block | Active comparator | Not described Receives: Procedure: Stellate Ganglion Block |
| Standard Treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in arrhythmic events
A ≥50% reduction in arrhythmic events (VT/VF)
Measured: 12 hours immediately after the blockade compared to the 12 hours immediately before
Secondary outcomes (2)
ICD therapies
Reduction in the number of ATPs/ICD shocks
Measured: 12 hours immediately after stellate ganglion block (SGB) compared to the 12 hours immediately before
Urgent ablation and other invasive therapies
urgent ablation and other invasive therapies (e.g., intra-aortic balloon pump placement or intubation for deep sedation)
Measured: 72 hours after the blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start6 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrical StormStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurício I Scanavacca, MD, PhD, Principal investigator, Instituto do Coração - HC/FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211347
- Sponsor's protocol ID
- 7.441.184
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savastano S, Baldi E, Compagnoni S, Rordorf R, Sanzo A, Gentile FR, Dusi V, Frea S, Gravinese C, Cauti FM, Iannopollo G, De Sensi F, Gandolfi E, Frigerio L, Crea P, Zagari D, Casula M, Sangiorgi G, Persampieri S, Dell'Era G, Patti G, Colombo C, Mugnai G, Notaristefano F, Barengo A, Falcetti R, Perego GB, D'Angelo G, Tanese N, Currao A, Sgromo V, De Ferrari GM; STAR study group. Electrical storm treatment by percutaneous stellate ganglion block: the STAR study. Eur Heart J. 2024 Mar 7;45(10):823-833. doi: 10.1093/eurheartj/ehae021.
PubMed 38289867
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Blockade Protocol of the Stellate Ganglion in Patients With Refractory Electrical Storm
- ClinicalTrials.gov ID
- NCT07211347
- Acronym / sponsor ID
- 7.441.184
- Keywords
- Ventricular Arrhythmia, Electrical Storm, Stellate ganglion block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Oct 2025 (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.
There is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm. So far, case reports and retrospective studies suggest that such a strategy should be considered in cases refractory to initial therapy. In this scenario, the European and American guidelines for the treatment of ventricular arrhythmias recommend autonomic modulation in this setting, but only with a level of recommendation IIb (1,2). This project aims to evaluate the effect of stellate ganglion infiltration in patients with electric storm refractory to initial clinical measures. It is a randomized clinical trial where patients will receive treatment with a lidocaine and bupivacaine anesthetic solution or no intervention. The effect of the intervention will be considered positive when there is a reduction of arrhythmic events of at least 50% in the 12 hours immediately after.
Detailed description
The study aims to evaluate the reduction of arrhythmic events following stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Hypothesis Stellate ganglion infiltration is an effective neuromodulation strategy for controlling arrhythmic events in patients with electrical storm awaiting definitive therapy.
Methodology This is a single-center randomized study investigating the efficacy of stellate ganglion blockade in patients with electrical storm refractory to initial clinical measures.
Participant Selection and Sample Size Participants will include patients admitted to the Emergency Unit or any Intensive Care Unit with a diagnosis of refractory electrical storm. Based on the STAR study, which reported a median of 6 arrhythmic events before SGB (IQR: 3 to 15.8), and aiming for at least a 50% reduction in arrhythmias in the active group post-procedure (with no expected change in the placebo group), a sample size of 32 patients per group was calculated (alpha = 0.05, power = 80%, two-tailed test).
Definitions Electrical storm (ES) is defined as three or more episodes of ventricular arrhythmias (including appropriate ICD therapies), separated by at least 5 minutes, within 24 hours. Refractory ES is defined as recurrent arrhythmias despite antiarrhythmic drug administration. Patients requiring discontinuation of antiarrhythmics due to adverse events will also be eligible for SGB. An arrhythmic event is defined as an episode of sustained VT or VF (>30 seconds or unstable), treated or not with antitachycardia pacing (ATP), electrical therapy, ICD shock, or external defibrillation. Pre-specified complications include: simple hematoma, hematoma requiring intervention, symptoms due to anesthetic absorption, brachial plexus injury, simple vascular injury, and vascular injury requiring intervention.
Randomization Randomization will be performed by a medical professional not involved in the infiltration procedure and blinded to data analysis, using the "Randomizer for Clinical Trial" software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block | Active comparator | Procedure: Stellate Ganglion Block |
| Standard Treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old with structural heart disease and a diagnosis of refractory electrical storm, or those who require discontinuation of antiarrhythmics due to adverse events or contraindications to standard therapy.
Key exclusion criteria (5 listed)
- Patients under 18
- History of heart transplant or prior cardiac denervation surgery
- Anatomical contraindications for the procedure (prior neck surgery, burns, large scars, or thyroid goiter).
- Genetically related polymorphic VT
- End-stage renal disease on dialysis
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 |
|---|---|---|
| Stellate Ganglion BlockThere is no randomized clinical study in the literature that evaluated the efficacy and safety of the stellate ganglion infiltration procedure in patients with electrical storm. | Procedure or surgery | Stellate Ganglion Block |
Primary outcome
Reduction in arrhythmic events
Time frame: 12 hours immediately after the blockade compared to the 12 hours immediately before
A ≥50% reduction in arrhythmic events (VT/VF)
2 secondary outcomes
ICD therapies
Time frame: 12 hours immediately after stellate ganglion block (SGB) compared to the 12 hours immediately before
Urgent ablation and other invasive therapies
Time frame: 72 hours after the blockade
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Background: PubMed 38289867Savastano S, Baldi E, Compagnoni S, Rordorf R, Sanzo A, Gentile FR, Dusi V, Frea S, Gravinese C, Cauti FM, Iannopollo G, De Sensi F, Gandolfi E, Frigerio L, Crea P, Zagari D, Casula M, Sangiorgi G, Persampieri S, Dell'Era G, Patti G, Colombo C, Mugnai G, Notaristefano F, Barengo A, Falcetti R, Perego GB, D'Angelo G, Tanese N, Currao A, Sgromo V, De Ferrari GM; STAR study group. Electrical storm treatment by percutaneous stellate ganglion block: the STAR study. Eur Heart J. 2024 Mar 7;45(10):823-833. doi: 10.1093/eurheartj/ehae021.
- Individual participant dataSharing planned: No
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Percutaneous Stellate Ganglion Block as First Line Treatment in Patients With Electrical Storm: the STAR 2 Study
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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.
Maurício I Scanavacca, MD, PhD principal investigator
Instituto do Coração - HC/FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stellate Ganglion Block in people with Electrical Storm and Stellate Ganglion Block, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 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: looking for participants now, as of the sponsor's last update on 7 Oct 2025. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto P Ferraz, MD (+5511981043839, albertopferraz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in arrhythmic events (time frame: 12 hours immediately after the blockade compared to the 12 hours immediately before). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07211347, which also lists 1 linked publication.
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 7 Oct 2025.