UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant (UMBRELLA)

January 29, 2018 updated by: Medtronic Bakken Research Center

UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic ICD Implant

The purpose of the study is to analyze the different patient profiles implanted with an Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant indication, arrhythmias incidence, treatments or device programming.

Study Overview

Status

Terminated

Conditions

Detailed Description

Umbrella is a prospective and retrospective cohort study.

Study Type

Observational

Enrollment (Actual)

4648

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • H. General de Alicante
      • Alicante, Spain
        • H. Universitario San Juan de Alicante
      • Almería, Spain
        • Complejo Hospitalario Torrecárdenas de Almería
      • Badajoz, Spain
        • H. Infanta Cristina
      • Barcelona, Spain
        • H. de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • H. Clínic i Provincial de Barcelona
      • Bilbao, Spain
        • H. de Basurto
      • Burgos, Spain
        • H. Universitario de Burgos
      • Ciudad Real, Spain
        • H. Gral de Ciudad Real
      • Cáceres, Spain
        • H. San Pedro de Alcántara
      • Cáceres, Spain
        • Complejo Hospitalario de Caceres
      • Córdoba, Spain
        • H. Reina Sofia
      • Granada, Spain
        • H.Universitario Virgen de las Nieves
      • Guadalajara, Spain
        • H.Universitario de Guadalajara
      • La Coruña, Spain
        • Complejo Hospitalario Universitario A Coruna
      • Las Palmas de Gran Canaria, Spain
        • H. Universitario Insular de las Palmas
      • León, Spain
        • H. de León
      • Madrid, Spain
        • H. Clínico San Carlos
      • Madrid, Spain
        • H. Infanta Leonor
      • Madrid, Spain
        • H. Universitario 12 de octubre
      • Madrid, Spain
        • H. Universitario Gregorio Marañón
      • Madrid, Spain
        • H. Universitario La Paz
      • Madrid, Spain
        • H. Universitario Ramón y Cajal
      • Murcia, Spain
        • H. General Universitario Reina Sofía
      • Murcia, Spain
        • H. Universitario Virgen de la Arrixaca
      • Málaga, Spain
        • H. Clínico Virgen de la Victoria
      • Palma de Mallorca, Spain
        • H. Son Llàtzer
      • Pamplona, Spain
        • H. de Navarra
      • Santa Cruz de Tenerife, Spain
        • H.Universitario Nuestra Señora de Candelaria
      • Santander, Spain
        • H. Universitario Marqués de Valdecilla
      • Sevilla, Spain
        • H. Universitario Nuestra Señora de Valme
      • Sevilla, Spain
        • H. Universitario Virgen Macarena
      • Tarragona, Spain
        • H. Universitario Joan XXIII
      • Toledo, Spain
        • Complejo Hospitalario de Toledo
      • Valencia, Spain
        • H. General Universitario de Valencia
      • Valencia, Spain
        • H. Universitario la Fe
      • Valladolid, Spain
        • H. Clínico Universitario de Valladolid
      • Vigo, Spain
        • Complejo Hospitalario Universitario de Vigo
    • Alicante
      • Elche, Alicante, Spain
        • H. General Universitario de Elche
    • Araba
      • Vitoria, Araba, Spain
        • H. de Txagorritxu
    • Asturias
      • Oviedo, Asturias, Spain
        • H. Universitario Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain
        • H. Universitari Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Barcelona, Spain
        • H. Universitari de Bellvitge
    • Coruña
      • Santiago de Compostela, Coruña, Spain
        • Complejo Hospitalario de Santiago
    • Guipúzcoa
      • Donostia, Guipúzcoa, Spain
        • Complejo Hospitalario Donostia
    • Madrid
      • Majadahonda, Madrid, Spain
        • H. Puerta de Hierro - Majadahonda
    • Murcia
      • Lorca, Murcia, Spain
        • H. Rafael Méndez
    • Santa Cruz De Tenerife
      • San Cristobal de la Laguna, Santa Cruz De Tenerife, Spain
        • H. Universitario de Canarias
    • Valencia
      • Alzira, Valencia, Spain
        • H. Universitario De La Ribera
    • Vizcaya
      • Barakaldo, Vizcaya, Spain
        • H. de Cruces
      • Galdakao, Vizcaya, Spain
        • H. Galdakao - Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients inplanted with an Implantable Cardiac Defibrillator (ICD) according to guidelines.

Description

Inclusion Criteria:

  • Patients with a Medtronic Implantable Cardiac Defibrillator (ICD) according to guidelines.
  • Patients with CareLink home Telemonitoring System.

Exclusion Criteria:

  • Unwillingness or inability to sign study written informed consent and/or CareLink consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD.
Time Frame: End of the study, an expected duration of 5 years.
End of the study, an expected duration of 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMBRELLA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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