Stellate Ganglion Neuromodulation for the Treatment of Electrical Storm

ConditionVentricular Tachycardia (V-Tach) Storm

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorPopulation Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Stellate Ganglion Block Injection with Bupivicaine
Procedure/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 control
Other intervention
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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Stellate Ganglion Block ArmExperimental treatment 1 intervention

Group B: Sham Procedure ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

72 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Hamilton Health Sciences Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: