Ventricular ArrhythmiasNCT07375264
Cardiac Sympathetic Denervation in Patients With Refractory Arrhythmic Storm: a Single-center Case Series
An observational study of Ventricular Arrhythmias and Electrical Storm, run by Jose Manuel López González at 1 site in Spain.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias, Electrical Storm, Stellate Ganglion Block
- What is being tested?
- Cardiac sympathetic denervation.
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2023to 15 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients over 18 years of age.
- arrhythmic storm refractory to conventional treatment.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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..
Read the 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.
- Being tested
- Cardiac sympathetic denervation.
- Keywords
- Stellate ganglion block, Cardiac sympathetic denervation, Electrical storm, Ventricular arrhythmias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac sympathetic denervation.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cardiac sympathetic denervation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start11 Apr 2023
- Primary completion13 Jan 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Jose Manuel López González
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Manuel López González, Fundación para la Investigación Biosanitaria del Principado de Asturias
- Investigators
- Daniel García Iglesias, MD.PhD, Principal investigator, Central University Hospital of Asturias, 33001, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375264
- Sponsor's protocol ID
- 2023/139
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37257955Zeppenfeld 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.
PubMed 36017572Gao D, Sapp JL. Electrical storm: definitions, clinical importance, and treatment. Curr Opin Cardiol. 2013 Jan;28(1):72-9. doi: 10.1097/HCO.0b013e32835b59db.
PubMed 23160339Baldi 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.
PubMed 39317656Savastano 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.
PubMed 38289867Patel 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.
PubMed 36725213Baldi 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.
PubMed 36196613
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Ultrasound-guided Percutaneous Bilateral Cardiac Sympathetic Denervation in Patients With Refractory Arrhythmic Storm: a Single-center Case Series
- ClinicalTrials.gov ID
- NCT07375264
- Acronym / sponsor ID
- 2023/139
- Keywords
- Stellate ganglion block, Cardiac sympathetic denervation, Electrical storm, Ventricular arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jose Manuel López GonzálezUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGB + BCSD. | – | Procedure: Cardiac sympathetic denervation.Patients with arrhythmic storm refractory to conservative medical treatment undergoing stellate ganglion block (SGB) and bilateral cardiac sympathetic denervation (BCSD) for arrhythmic storm control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients over 18 years of age.
- arrhythmic storm refractory to conventional treatment.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac sympathetic denervation.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. | Procedure or surgery | SGB + BCSD. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Results publication: PubMed 37257955Jentzer 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.
- Results publication: PubMed 36017572Zeppenfeld 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.
- Results publication: PubMed 23160339Gao D, Sapp JL. Electrical storm: definitions, clinical importance, and treatment. Curr Opin Cardiol. 2013 Jan;28(1):72-9. doi: 10.1097/HCO.0b013e32835b59db.
- Results publication: PubMed 39317656Baldi 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.
- Results publication: PubMed 38289867Savastano 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.
- Results publication: PubMed 36725213Patel 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.
- Results publication: PubMed 36196613Baldi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel García Iglesias, MD.PhD principal investigator
Central University Hospital of Asturias, 33001, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrhythmias and Electrical Storm, run by Jose Manuel López González at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07375264, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.