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CardiomyopathiesUMBRELLANCT01561144

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

An observational study of Cardiomyopathies and Cardiac Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 51 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
4,648 participants
Where
51 sitesSpain
Study dates
Aug 2011to Nov 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

Spain51 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • H. General de Alicante

    Alicante

  • H. Universitario San Juan de Alicante

    Alicante

  • Complejo Hospitalario Torrecárdenas de Almería

    Almería

  • H. Universitario De La Ribera

    Alzira, Valencia

  • H. Infanta Cristina

    Badajoz

  • H. Universitari Germans Trias i Pujol

    Badalona, Barcelona

  • H. de Cruces

    Barakaldo, Vizcaya

  • H. Clinic I Provincial de Barcelona

    Barcelona

  • H. de la Santa Creu i Sant Pau

    Barcelona

  • H. de Basurto

    Bilbao

  • H. Universitario de Burgos

    Burgos

  • Complejo Hospitalario de Cáceres

    Cáceres

  • H. San Pedro de Alcántara

    Cáceres

  • H. Gral de Ciudad Real

    Ciudad Real

  • H. Reina Sofía

    Córdoba

  • Complejo Hospitalario Donostia

    Donostia / San Sebastian, Guipúzcoa

  • H. General Universitario de Elche

    Elche, Alicante

  • H. Galdakao - Usansolo

    Galdakao, Vizcaya

  • H.Universitario Virgen de las Nieves

    Granada

  • H.Universitario de Guadalajara

    Guadalajara

  • H. Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

  • H. Universitario Insular de las Palmas

    Las Palmas de Gran Canaria

  • H. De León

    León

  • H. Rafael Méndez

    Lorca, Murcia

  • H. Clínico San Carlos

    Madrid

  • H. Infanta Leonor

    Madrid

  • H. Universitario 12 de Octubre

    Madrid

  • H. Universitario Gregorio Marañón

    Madrid

  • H. Universitario La Paz

    Madrid

  • H. Universitario Ramón y Cajal

    Madrid

  • H. Puerta de Hierro - Majadahonda

    Majadahonda, Madrid

  • H. Clínico Virgen de la Victoria

    Málaga

  • H. General Universitario Reina Sofía

    Murcia

  • H. Universitario Virgen de la Arrixaca

    Murcia

  • H. Universitario Central de Asturias

    Oviedo, Principality of Asturias

  • H. Son Llátzer

    Palma de Mallorca

  • H. de Navarra

    Pamplona

  • H. Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife

  • H.Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife

  • H. Universitario Marqués de Valdecilla

    Santander

  • Complejo Hospitalario de Santiago

    Santiago de Compostela, Coruña

  • H. Universitario Nuestra Señora de Valme

    Seville

  • H. Universitario Virgen Macarena

    Seville

  • H. Universitario Joan XXIII

    Tarragona

  • Complejo Hospitalario de Toledo

    Toledo

  • H. General Universitario de Valencia

    Valencia

  • H. Universitario la Fe

    Valencia

  • H. Clínico Universitario de Valladolid

    Valladolid

  • Complejo Hospitalario Universitario de Vigo

    Vigo

  • H. de Txagorritxu

    Vitoria-Gasteiz, Araba

Other trials in Spain

About this study

Official title: 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.

Read the detailed description

Umbrella is a prospective and retrospective cohort study.

Keywords
Defibrillators, Implantable, Cardiac arrhythmias, Heart Disease
Medical subject headings
Cardiomyopathies, Arrhythmias, Cardiac, Heart Arrest, Heart Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD.

    Measured: End of the study, an expected duration of 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
4,648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01561144
Sponsor's protocol ID
UMBRELLA
Acronym
UMBRELLA
Status last verified
Jun 2025
First submitted
16 Mar 2012
Last updated
8 Jul 2025
Results posted
No

Publications

  • Briongos-Figuero S, Garcia-Alberola A, Rubio J, Segura JM, Rodriguez A, Peinado R, Alzueta J, Martinez-Ferrer JB, Vinolas X, Fernandez de la Concha J, Anguera I, Martin M, Cerda L, Perez L; UMBRELLA Investigators *. Long-Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter-Defibrillator: UMBRELLA Study Final Results. J Am Heart Assoc. 2021 Jan 5;10(1):e018108. doi: 10.1161/JAHA.120.018108. Epub 2020 Dec 25.

    PubMed 33356406

  • Loughlin G, Datino T, Arenal A, Ruiz-Granell R, Sanchez-Gomez JM, Perez L, Martinez-Ferrer J, Alzueta J, Perez-Lorente F, Vinolas X, Fidalgo Andres ML, Fernandez de la Concha J. Predictors of adoption and impact of evidence-based programming on the incidence of implantable cardioverter-defibrillator therapies. Rev Esp Cardiol (Engl Ed). 2021 Apr;74(4):296-302. doi: 10.1016/j.rec.2020.06.017. Epub 2020 Aug 6. English, Spanish.

    PubMed 32773348

  • Lillo-Castellano JM, Marina-Breysse M, Gomez-Gallanti A, Martinez-Ferrer JB, Alzueta J, Perez-Alvarez L, Alberola A, Fernandez-Lozano I, Rodriguez A, Porro R, Anguera I, Fontenla A, Gonzalez-Ferrer JJ, Canadas-Godoy V, Perez-Castellano N, Garofalo D, Salvador-Montanes O, Calvo CJ, Quintanilla JG, Peinado R, Mora-Jimenez I, Perez-Villacastin J, Rojo-Alvarez JL, Filgueiras-Rama D. Safety threshold of R-wave amplitudes in patients with implantable cardioverter defibrillator. Heart. 2016 Oct 15;102(20):1662-70. doi: 10.1136/heartjnl-2016-309295. Epub 2016 Jun 13.

    PubMed 27296239

  • Anguera I, Dallaglio P, Martinez-Ferrer J, Rodriguez A, Alzueta J, Perez-Villacastin J, Porres JM, Vinolas X, Fontenla A, Fernandez-Lozano I, Garcia-Alberola A, Sabate X. Shock Reduction With Multiple Bursts of Antitachycardia Pacing Therapies to Treat Fast Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter Defibrillators: A Multicenter Study. J Cardiovasc Electrophysiol. 2015 Jul;26(7):774-82. doi: 10.1111/jce.12699. Epub 2015 May 28.

    PubMed 25916814

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiomyopathies and Cardiac Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 51 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01561144, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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