Ventricular Tachycardia (V-Tach) StormSTORM-OFFNCT07857889
Stellate Ganglion Neuromodulation for the Treatment of Electrical Storm
A study testing Stellate Ganglion Block Injection with Bupivicaine in people with Ventricular Tachycardia (V-Tach) Storm, run by Population Health Research Institute at 1 site in Canada.
Trial summary
Ventricular tachycardia (VT) is a serious heart rhythm problem in which the heart beats very fast and in an abnormal way. These abnormal heart rhythms can be life-threatening. When a person has three or more episodes of VT within a 24-hour period, it is called a "VT storm." VT storm can be difficult to treat because… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (V-Tach) Storm
- What is being tested?
- Stellate Ganglion Block Injection with Bupivicaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2027to Jul 2031
- Phase
- Interventional
- 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
- Age ≥18 years
- ≥3 VT/VF episodes within 24 hours (including appropriate shock or antitachycardia pacing (ATP) terminated events) VT/VF episode definition: ventricular tachyarrhythmia episode ≥30 seconds in duration (VT or VF) requiring intervention regardless of duration, as captured on telemetry, ECG or device intracardiac electrogram.
- <12 hr since last VT/VF episode
Who cannot join
- Standard clinical contraindications to nerve block (e.g., overlying site infection/allergy to the drug, cervical mass or history of neck cancer in the anticipated needle trajectory, others)
- VT storm secondary to underlying ion channelopathies (LQTS, SQTS, Brugada, CPVT, or CRDS)
- History of cardiac transplant or cardiac sympathetic denervation (CSD)
- Platelet count <50,000 /µL
- VT/VF occurring in the setting of acute coronary syndrome prior to revascularization
- VT storm due to reversible causes (metabolic, drug mediated, etc.)
- Inability to obtain consent (from patient OR substitute decision maker)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: STellate gangliOn neuRoModulatiOn For the Treatment oF Electrical Storm: a Randomized Sham-controlled Trial (STORM-OFF)
Ventricular tachycardia (VT) is a serious heart rhythm problem in which the heart beats very fast and in an abnormal way. These abnormal heart rhythms can be life-threatening. When a person has three or more episodes of VT within a 24-hour period, it is called a "VT storm." VT storm can be difficult to treat because some patients do not respond well to standard medications. Some studies suggest that a procedure called a stellate ganglion block (SGB) may help. An SGB involves injecting a local anesthetic near a group of nerves in the neck that help control signals between the brain and the heart. The procedure can be performed at the bedside using ultrasound guidance.
The purpose of this study is to find out whether SGB can delay or prevent the return of dangerous abnormal heart rhythms in patients with VT storm who are receiving care in an intensive care unit.
Read more
If a patient joins the study, they will be randomly assigned (by chance, like flipping a coin) to one of two groups. One group will receive a real stellate ganglion block. The other group will receive a sham procedure, in which a blunt needle will touch the skin but no injection will be given. Patients in the sham group who continue to experience VT may later receive the real procedure.
Participants will be followed until they leave the hospital or for 30 days after joining the study, whichever comes first. The study will take place at five hospitals across Ontario.
Read the detailed description
Stellate ganglion block (SGB) is currently a standard of care option for ventricular tachycardia (VT) storm. However, the evidence to support SBG is derived from non-randomized studies, thus there is a need to test this clinical procedure in an RCT with a sham procedure control. All aspects of the SGB intervention will occur in accordance with local clinical practice, with the exception of control arm participants receiving a sham injection as described below and in the protocol. The study case report forms will be used to collect information related to the local clinical assessments and procedures, as well as participant clinical status and outcomes, but will not dictate local clinical care.
Study summary:
Patients admitted to hospital with VT storm will be approached by study nurse or physician to gain consent for study participation. Study nurse or physician will use web-based randomization (ROME) to allocate participant to intervention or control arm. All participants who give consent will receive aseptic preparation and draping of the site of intervention, scanning with ultrasonography, and marking the site of needle entry with a plastic needle cap, in accordance with local practices. In both arms, a syringe with 10mL 0.5% bupivacaine will be ordered from local clinical supplies and prepared in accordance with institutional practices. The operator will document the intervention delivered in a dedicated case report form. All patients will undergo continuous ECG/telemetry monitoring and ICD interrogation (if applicable) per standard clinical care, for 72 hours following SGB.
SGB Arm:
SGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes.
Sham procedure arm:
The sham-procedure will use the identical preparatory and procedural steps as described for the active arm. The procedure area will be screened off from the patient's view, and all equipment used in both active and sham arms will be identical and visible in the room. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. A small dressing will be applied to the site in both groups to further conceal which intervention was performed. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will image the stellate ganglion using ultrasound but will not inject it. The operator will discard the unused bupivacaine to maintain blinding.
The study database will be hosted within PHRI's secure data centre, and eCRFs, including those pertaining to participant status and outcomes, will be completed by local site research assistants from available local medical records. No participant questionnaires or study-specific research tests or assessments are included in the protocol.
- Conditions
- Ventricular Tachycardia (V-Tach) Storm
- Being tested
- Stellate Ganglion Block Injection with Bupivicaine, Sham procedure control
- Keywords
- Ventricular tachycardia, Stellate ganglion block
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion Block Injection with BupivicaineProcedure or surgery
SGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB should typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes.
Sham procedure controlOther
The sham-procedure will use the identical preparatory and procedure steps as described for the active arm. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will discard the unused bupivacaine to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block Arm | Experimental | SGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB should typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes. Receives: Procedure: Stellate Ganglion Block Injection with Bupivicaine |
| Sham Procedure Arm | Sham comparator | The sham-procedure will use the identical preparatory and procedure steps as described for the active arm. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will discard the unused bupivacaine to maintain blinding. Receives: Other: Sham procedure control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Ventricular Tachycardia/Ventricular Fibrillation
The primary outcome is the time to first recurrence of sustained VT/VF during the first 72 hours after randomization, following a 15-minute blanking period post intervention.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (V-Tach) StormStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857889
- Sponsor's protocol ID
- STORM-OFF
- Acronym
- STORM-OFF
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STellate gangliOn neuRoModulatiOn For the Treatment oF Electrical Storm: a Randomized Sham-controlled Trial (STORM-OFF)
- ClinicalTrials.gov ID
- NCT07857889
- Acronym / sponsor ID
- STORM-OFF / STORM-OFF
- Conditions
- Ventricular Tachycardia (V-Tach) Storm
- Keywords
- Ventricular tachycardia, Stellate ganglion block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Hospital
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 5 Oct 2026 (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.
Ventricular tachycardia (VT) is a serious heart rhythm problem in which the heart beats very fast and in an abnormal way. These abnormal heart rhythms can be life-threatening. When a person has three or more episodes of VT within a 24-hour period, it is called a "VT storm." VT storm can be difficult to treat because some patients do not respond well to standard medications. Some studies suggest that a procedure called a stellate ganglion block (SGB) may help. An SGB involves injecting a local anesthetic near a group of nerves in the neck that help control signals between the brain and the heart. The procedure can be performed at the bedside using ultrasound guidance.
The purpose of this study is to find out whether SGB can delay or prevent the return of dangerous abnormal heart rhythms in patients with VT storm who are receiving care in an intensive care unit.
If a patient joins the study, they will be randomly assigned (by chance, like flipping a coin) to one of two groups. One group will receive a real stellate ganglion block. The other group will receive a sham procedure, in which a blunt needle will touch the skin but no injection will be given. Patients in the sham group who continue to experience VT may later receive the real procedure.
Participants will be followed until they leave the hospital or for 30 days after joining the study, whichever comes first. The study will take place at five hospitals across Ontario.
Detailed description
Stellate ganglion block (SGB) is currently a standard of care option for ventricular tachycardia (VT) storm. However, the evidence to support SBG is derived from non-randomized studies, thus there is a need to test this clinical procedure in an RCT with a sham procedure control. All aspects of the SGB intervention will occur in accordance with local clinical practice, with the exception of control arm participants receiving a sham injection as described below and in the protocol. The study case report forms will be used to collect information related to the local clinical assessments and procedures, as well as participant clinical status and outcomes, but will not dictate local clinical care.
Study summary:
Patients admitted to hospital with VT storm will be approached by study nurse or physician to gain consent for study participation. Study nurse or physician will use web-based randomization (ROME) to allocate participant to intervention or control arm. All participants who give consent will receive aseptic preparation and draping of the site of intervention, scanning with ultrasonography, and marking the site of needle entry with a plastic needle cap, in accordance with local practices. In both arms, a syringe with 10mL 0.5% bupivacaine will be ordered from local clinical supplies and prepared in accordance with institutional practices. The operator will document the intervention delivered in a dedicated case report form. All patients will undergo continuous ECG/telemetry monitoring and ICD interrogation (if applicable) per standard clinical care, for 72 hours following SGB.
SGB Arm:
SGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes.
Sham procedure arm:
The sham-procedure will use the identical preparatory and procedural steps as described for the active arm. The procedure area will be screened off from the patient's view, and all equipment used in both active and sham arms will be identical and visible in the room. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. A small dressing will be applied to the site in both groups to further conceal which intervention was performed. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will image the stellate ganglion using ultrasound but will not inject it. The operator will discard the unused bupivacaine to maintain blinding.
The study database will be hosted within PHRI's secure data centre, and eCRFs, including those pertaining to participant status and outcomes, will be completed by local site research assistants from available local medical records. No participant questionnaires or study-specific research tests or assessments are included in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block Arm | Experimental | Procedure: Stellate Ganglion Block Injection with BupivicaineSGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB should typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes. |
| Sham Procedure Arm | Sham comparator | Other: Sham procedure controlThe sham-procedure will use the identical preparatory and procedure steps as described for the active arm. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will discard the unused bupivacaine to maintain blinding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- ≥3 VT/VF episodes within 24 hours (including appropriate shock or antitachycardia pacing (ATP) terminated events) VT/VF episode definition: ventricular tachyarrhythmia episode ≥30 seconds in duration (VT or VF) requiring intervention regardless of duration, as captured on telemetry, ECG or device intracardiac electrogram.
- <12 hr since last VT/VF episode
Key exclusion criteria (7 listed)
- Standard clinical contraindications to nerve block (e.g., overlying site infection/allergy to the drug, cervical mass or history of neck cancer in the anticipated needle trajectory, others)
- VT storm secondary to underlying ion channelopathies (LQTS, SQTS, Brugada, CPVT, or CRDS)
- History of cardiac transplant or cardiac sympathetic denervation (CSD)
- Platelet count <50,000 /µL
- VT/VF occurring in the setting of acute coronary syndrome prior to revascularization
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 Block Injection with BupivicaineSGB will be performed according to local practice. Local anesthesia will be delivered subcutaneously prior to the procedure. SGB should typically occurs under dynamic ultrasound guidance. Once a landmark for the SGB is identified (e.g., the C6 anterior tubercle), 10 mL of 0.5% bupivacaine will be injected into the left side of the neck using a 22-25G nerve block spinal needle ventral to the longus colli muscle and beneath the prevertebral fascia. This will be a one-time injection. The efficacy of the block will be assessed qualitatively by the operator at the time of the procedure. Any unused bupivacaine will be discarded. The procedure typically takes approximately 20 minutes. | Procedure or surgery | Stellate Ganglion Block Arm |
| Sham procedure controlThe sham-procedure will use the identical preparatory and procedure steps as described for the active arm. The duration of the sham procedure will match that of the active intervention, and communication during the procedure will be standardized for both arms. Once the skin is draped and cleaned, control arm participants will have 1 mL of 0.5% bupivacaine injected, subcutaneously only. The operator will discard the unused bupivacaine to maintain blinding. | Other | Sham Procedure Arm |
Primary outcome
Time to First Ventricular Tachycardia/Ventricular Fibrillation
Time frame: 72 hours
The primary outcome is the time to first recurrence of sustained VT/VF during the first 72 hours after randomization, following a 15-minute blanking period post intervention.
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block Injection with Bupivicaine in people with Ventricular Tachycardia (V-Tach) Storm, run by Population Health Research Institute at 1 site in Canada.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Canada. 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.
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 Project Manager (905-521-2100, STORM-OFF@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Ventricular Tachycardia/Ventricular Fibrillation (time frame: 72 hours). 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 8 Oct 2026.