- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375264
Cardiac Sympathetic Denervation in Patients With Refractory Arrhythmic Storm: a Single-center Case Series
January 28, 2026 updated by: Jose Manuel López González
Long-term Outcomes of Ultrasound-guided Percutaneous Bilateral Cardiac Sympathetic Denervation in Patients With Refractory Arrhythmic Storm: a Single-center Case Series
The objective of our study was to evaluate the effectiveness of stellate ganglion block (SGB) and of the bilateral cardiac sympathetic denervation (BCSD) in patients with electrical storm refractory to conventional treatment..
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
A prospective, single-center observational study was designed with the aim of evaluate the safety and short-term efficacy of SGB within the first 24 hours, as well as the long-term effectiveness of ultrasound-guided percutaneous BCSD at 12 months, in patients with refractory electrical storm.
Study Type
Observational
Enrollment (Actual)
18
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Principality of Asturias
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Oviedo, Principality of Asturias, Spain, 33001
- FINBA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
After approval of the study by Principality of Asturias Drug Research Ethics Committee (CEImPA), Spain and obtaining informed consent from the participants, all consecutive patients who underwent SGB followed by BCSD as part of the treatment for refractory electrical storm were included.
Description
Inclusion Criteria:
- patients over 18 years of age.
- arrhythmic storm refractory to conventional treatment.
Exclusion Criteria:
- patients younger than 18 years of age.
- previous history of heart transplantation.
- history of previous surgical cardiac sympathetic denervation.
- patients with neck anatomy considered unsuitable for the procedure (including previous neck surgery, burns, the presence of extensive scars, or large goiters with significant displacement of adjacent structures).
- contraindications to the interventional technique (such as infection at the puncture site, or refusal to provide consent).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SGB + BCSD.
Patients with arrhythmic storm refractory to conservative medical treatment undergoing stellate ganglion block (SGB) and bilateral cardiac sympathetic denervation (BCSD) for arrhythmic storm control.
|
Patients underwent stellate ganglion block with 10 ml of levobupivacaine 0.25% and subsequently ultrasound-guided percutaneous bilateral cardiac sympathetic denervation , two neuroablative lesions were created using conventional radiofrequency treatment at 60°C, 20 V for 90 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arrhythmic burden.
Time Frame: The arrhythmic burden was assessed both in the early period (first 24 hours following SGB) and in the long term (during the 12 months following BCSD).
|
The arrhythmic burden was quantified by the number of sustained ventricular arrhythmias, antitachycardia pacing (ATP) therapies, and ICD (implantable cardioverter-defibrillator) shocks recorded during the follow-up period.
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The arrhythmic burden was assessed both in the early period (first 24 hours following SGB) and in the long term (during the 12 months following BCSD).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel García Iglesias, MD.PhD, Central University Hospital of Asturias, 33001, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jentzer JC, Noseworthy PA, Kashou AH, May AM, Chrispin J, Kabra R, Arps K, Blumer V, Tisdale JE, Solomon MA; American College of Cardiology Critical Care Cardiology and Electrophysiology Sections. Multidisciplinary Critical Care Management of Electrical Storm: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023 Jun 6;81(22):2189-2206. doi: 10.1016/j.jacc.2023.03.424.
- Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.
- Gao D, Sapp JL. Electrical storm: definitions, clinical importance, and treatment. Curr Opin Cardiol. 2013 Jan;28(1):72-9. doi: 10.1097/HCO.0b013e32835b59db.
- Baldi E, Dusi V, Rordorf R, Currao A, Compagnoni S, Sanzo A, Gentile FR, Frea S, Gravinese C, Angelini F, Cauti FM, Iannopollo G, De Sensi F, Gandolfi E, Frigerio L, Crea P, Zagari D, Casula M, Binaghi G, Sangiorgi G, Barone L, Persampieri S, Dell'Era G, Patti G, Colombo C, Mugnai G, Tavella D, Notaristefano F, Barengo A, Falcetti R, Girardengo G, D'Angelo G, Tanese N, Sgromo V, De Ferrari GM, Savastano S; all the STAR study group. Efficacy of early use of percutaneous stellate ganglion block for electrical storms. Eur Heart J Acute Cardiovasc Care. 2024 Dec 3;13(11):757-765. doi: 10.1093/ehjacc/zuae109.
- 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.
- Patel RA, Condrey JM, George RM, Wolf BJ, Wilson SH. Stellate ganglion block catheters for refractory electrical storm: a retrospective cohort and care pathway. Reg Anesth Pain Med. 2023 May;48(5):224-228. doi: 10.1136/rapm-2022-104172. Epub 2023 Feb 1.
- Baldi E, Conte G, Zeppenfeld K, Lenarczyk R, Guerra JM, Farkowski MM, de Asmundis C, Boveda S. Contemporary management of ventricular electrical storm in Europe: results of a European Heart Rhythm Association Survey. Europace. 2023 Apr 15;25(4):1277-1283. doi: 10.1093/europace/euac151.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2023
Primary Completion (Actual)
January 13, 2025
Study Completion (Actual)
December 15, 2025
Study Registration Dates
First Submitted
January 21, 2026
First Submitted That Met QC Criteria
January 21, 2026
First Posted (Actual)
January 29, 2026
Study Record Updates
Last Update Posted (Actual)
January 30, 2026
Last Update Submitted That Met QC Criteria
January 28, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023/139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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