NCT07375264

Brief Summary

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..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 21, 2026

Last Update Submit

January 28, 2026

Conditions

Electrical StormStellate Ganglion BlockVentricular Arrhythmias

Keywords

Stellate ganglion blockCardiac sympathetic denervationElectrical stormVentricular arrhythmias

Outcome Measures

Primary Outcomes (1)

  • Arrhythmic burden.

    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.

    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).

Study Arms (1)

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.

Procedure: Cardiac sympathetic denervation.

Interventions

Cardiac sympathetic denervation.PROCEDURE

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.

SGB + BCSD.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patients over 18 years of age.
  • arrhythmic storm refractory to conventional treatment.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FINBA

Oviedo, Principality of Asturias, 33001, Spain

Location

Related Publications (7)

  • 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.

    PMID: 37257955RESULT

  • 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.

    PMID: 36017572RESULT

  • 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.

    PMID: 23160339RESULT

  • 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.

    PMID: 39317656RESULT

  • 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.

    PMID: 38289867RESULT

  • 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.

    PMID: 36725213RESULT

  • 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.

    PMID: 36196613RESULT

Study Officials

  • Daniel García Iglesias, MD.PhD

    Central University Hospital of Asturias, 33001, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD. Consultant Anesthesiologist and Pain Physician

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

April 11, 2023

Primary Completion

January 13, 2025

Study Completion

December 15, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

ES(1)