NCT07211347 Percutaneous Blockade of the Stellate Ganglion in Electrical Storm
| NCT ID | NCT07211347 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Electrical Storm |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2025-06-06 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Maurício I Scanavacca, MD, PhD
PRINCIPAL INVESTIGATOR
Instituto do Coração - HC/FMUSP
Frequently Asked Questions
Who can join the NCT07211347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Electrical Storm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07211347 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07211347 currently recruiting?
Yes, NCT07211347 is actively recruiting participants. Contact the research team at albertopferraz@gmail.com for enrollment information.
Where is the NCT07211347 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07211347 clinical trial?
NCT07211347 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Maurício I Scanavacca, MD, PhD at Instituto do Coração - HC/FMUSP. The trial plans to enroll 64 participants.