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International Electrical Storm Registry

NCT02882139 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2018-10-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-08-31
Completion
2021-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02882139 on ClinicalTrials.gov