International Electrical Storm Registry

  • STATUS
    Recruiting
  • End date
    Aug 22, 2021
  • participants needed
    500
  • sponsor
    Università Politecnica delle Marche
Updated on 22 January 2021
arrhythmia
heart disease
fibrillation
secondary prevention
ventricular arrhythmia
ventricular tachycardia
cardiac death
primary prevention
sudden cardiac death
torsades de pointes
sustained ventricular tachycardia

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.

Details
Condition Arrhythmia, Implantable defibrillator, Ventricular tachycardia, Ventricular Fibrillation, Dysrhythmia
Clinical Study IdentifierNCT02882139
SponsorUniversità Politecnica delle Marche
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Ventricular Fibrillation or Implantable defibrillator or Ventricular tachycardia or Arrhythmia?
Do you have any of these conditions: Implantable defibrillator or Ventricular Fibrillation or Arrhythmia or Dysrhythmia or Ventricular tachycardia?
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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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