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

July 2, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Umbrella is a prospective and retrospective cohort study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Cáceres
      • Córdoba, Spain
        • H. Reina Sofía
      • Granada, Spain
        • H.Universitario Virgen de las Nieves
      • Guadalajara, Spain
        • H.Universitario de Guadalajara
      • La Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña
      • 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 Llatzer
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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