International Electrical Storm Registry (ELECTRA)
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|ClinicalTrials.gov Identifier: NCT02882139|
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : October 17, 2018
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:
- To create an international registry on clinical features, optimal therapy, ablation strategy, prognosis and the effect of ICD programming on patients with ES.
- To use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with ES.
|Condition or disease|
|Arrhythmias, Cardiac Tachycardia, Ventricular Ventricular Fibrillation Defibrillators, Implantable|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Multicenter Registry on Patients Affected by Electrical Storm|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2021|
Documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h
- All-cause mortality [ Time Frame: Three years ]
- Hospitalization for all causes [ Time Frame: Three years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882139
|Contact: Federico Guerra, M.D.||+email@example.com|
|Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital "Ospedali Riuniti"||Recruiting|
|Ancona, Italy, 60126|
|Contact: Paolo Bonelli, MD +390715966593 firstname.lastname@example.org|