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International Electrical Storm Registry

Multicenter Registry on Patients Affected by Electrical Storm

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02882139
Acronym
ELECTRA
Enrollment
500
Registered
2016-08-29
Start date
2016-08-31
Completion date
2021-08-31
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac, Defibrillators, Implantable, Tachycardia, Ventricular, Ventricular Fibrillation

Keywords

Electrical storm

Brief summary

Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP) and ventricular fibrillation (VF)) represent a major event in the clinical history of a patient and they can lead to hemodynamic instability and sudden cardiac death (SCD). Recurrences of ventricular arrhythmias and electrical instability have exponentially increased in the last decades and a new clinical entity called electrical storm (ES) has emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia lasting 12 hours or more and that does not respond to treatments. Most of the patients presenting ES are already implanted with an ICD. This is due to 3 factors: first, patients with ICD implant are at higher risk to develop ventricular arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not be detected. Third, and more important, the device gives the possibility to survive to an arrhythmic episode, making it possible for the patient to experience an ES. The incidence of ES is debated in different studies and ranges from 10 to 60% in patients with ICD for secondary prevention and from 4 to 7% in patients with ICD for primary prevention. The aim of the ELECTRA registry is twofold: 1. To create an international registry on clinical features, optimal therapy, ablation strategy, prognosis and the effect of ICD programming on patients with ES. 2. To use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with ES.

Interventions

None listed

Sponsors

Università Politecnica delle Marche
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of ES (documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h).In order to fulfill this criterion, a patient with a previous episode of ES could also be enrolled during routine screening. * Age ≥18 * Written informed consent

Exclusion criteria

* patient without ICD * Confirmed or suspected use of drugs or narcotics with known direct pro-arrhythmic effect * Inability to express an informed consent for the study

Design outcomes

Primary

MeasureTime frame
All-cause mortalityThree years

Secondary

MeasureTime frame
Hospitalization for all causesThree years

Countries

Italy

Contacts

Primary ContactFederico Guerra, M.D.
f.guerra@univpm.it+390715966593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026