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Trial record 37 of 727 for:    Recruiting, Not yet recruiting, Available Studies | "Arrhythmias, Cardiac"

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
Sponsor:
Information provided by (Responsible Party):
Federico Guerra, Università Politecnica delle Marche

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.

Condition or disease
Arrhythmias, Cardiac Tachycardia, Ventricular Ventricular Fibrillation Defibrillators, Implantable

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Other
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


Group/Cohort
Electrical storm
Documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h



Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. Hospitalization for all causes [ Time Frame: Three years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients will be enrolled for a minimum of three years from the protocol approval. There is no pre-specified date for the end of enrollment, which will be decided by the study responsible according to the enrollment rate.

A minimum of 500 patients will be included in the present registry. The exploratory nature intrinsic to the registry characteristics does not allow a sample size calculation by statistical means. However, the sample presented is based on the estimated enrolment rates of the participating centers during a 3-year enrolment period. Moreover, the sample size is large enough to postulate specific subgroup analyses.

Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Federico Guerra, M.D. +390715966593 f.guerra@univpm.it

Locations
Italy
Cardiology and Arrhythmology Clinic, Marche Polytechnic University, University Hospital "Ospedali Riuniti" Recruiting
Ancona, Italy, 60126
Contact: Paolo Bonelli, MD    +390715966593    electraregistry@gmail.com   
Sponsors and Collaborators
Università Politecnica delle Marche
  Study Documents (Full-Text)

Documents provided by Federico Guerra, Università Politecnica delle Marche:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Federico Guerra, Dr., Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT02882139     History of Changes
Other Study ID Numbers: 2016-0364 OR
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Keywords provided by Federico Guerra, Università Politecnica delle Marche:
Electrical storm

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Arrhythmias, Cardiac
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Pathologic Processes