Percutaneous stellate ganglion block for electrical storm
Percutaneous Blockade Protocol of the Stellate Ganglion in Patients With Refractory Electrical Storm
This trial will try a targeted nerve block using lidocaine and bupivacaine to stop repeated ventricular arrhythmias in adults whose electrical storm hasn't responded to initial treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07211347 on ClinicalTrials.gov |
What this trial studies
This single-center randomized trial enrolls adults with refractory electrical storm admitted to the emergency unit or ICU. Participants are randomized to receive a percutaneous stellate ganglion block with a lidocaine/bupivacaine solution or no intervention. The primary outcome is a reduction in arrhythmic events by at least 50% during the 12 hours after the procedure, and the planned sample size is 32 patients per group. The procedure is intended as a temporizing neuromodulation measure for patients awaiting definitive therapy.
Who should consider this trial
Good fit: Adults with structural heart disease experiencing refractory electrical storm in the emergency department or ICU who have failed or cannot tolerate standard antiarrhythmic therapy.
Not a fit: Patients without refractory electrical storm, those with prior cardiac denervation or heart transplant, or those with anatomical contraindications to neck procedures are unlikely to benefit.
Why it matters
Potential benefit: If successful, the procedure could rapidly reduce dangerous ventricular arrhythmias and stabilize patients who have not responded to standard therapies.
How similar studies have performed: Case reports and retrospective series suggest stellate ganglion blockade can reduce arrhythmias, but no randomized trials have previously tested this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
São Paulo, São Paulo
- Clinical Research Center of the Heart Institute - University of São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Maurício I Scanavacca, MD, PhD — Instituto do Coração - HC/FMUSP
- Study coordinator: Alberto P Ferraz, MD
- Email: albertopferraz@gmail.com
- Phone: +5511981043839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.