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TerminatedNCT01561144UMBRELLAUpdated Jul 8, 2025

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

An observational study in Cardiomyopathies, Cardiac Arrhythmias and Cardiac Arrest, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Terminated at 51 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
4,648
Ages
18 Years and older
Sex
All
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Study 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 the detailed description

Umbrella is a prospective and retrospective cohort study.

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Conditions studied

  • Cardiomyopathies
  • Cardiac Arrhythmias
  • Cardiac Arrest

Keywords

  • Defibrillators, Implantable
  • Cardiac arrhythmias
  • Heart Disease
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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 4,648 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Other
Enrollment
4,648 participants (actual)
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What researchers measure

Primary outcomes

  1. 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.

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Study locations

51 sites
  • H. General Universitario de Elche
    Elche, Alicante, Spain
  • H. de Txagorritxu
    Vitoria-Gasteiz, Araba, Spain
  • H. Universitari Germans Trias i Pujol
    Badalona, Barcelona, Spain
  • H. Universitari de Bellvitge
    L'Hospitalet de Llobregat, Barcelona, Spain
  • Complejo Hospitalario de Santiago
    Santiago de Compostela, Coruña, Spain
  • Complejo Hospitalario Donostia
    Donostia / San Sebastian, Guipúzcoa, Spain
  • H. Puerta de Hierro - Majadahonda
    Majadahonda, Madrid, Spain
  • H. Rafael Méndez
    Lorca, Murcia, Spain
  • H. Universitario Central de Asturias
    Oviedo, Principality of Asturias, Spain
  • H. Universitario de Canarias
    San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
  • H. Universitario De La Ribera
    Alzira, Valencia, Spain
  • H. de Cruces
    Barakaldo, Vizcaya, Spain
  • H. Galdakao - Usansolo
    Galdakao, Vizcaya, Spain
  • Complejo Hospitalario Universitario A Coruña
    A Coruña, Spain
  • H. General de Alicante
    Alicante, Spain
  • H. Universitario San Juan de Alicante
    Alicante, Spain
  • Complejo Hospitalario Torrecárdenas de Almería
    Almería, Spain
  • H. Infanta Cristina
    Badajoz, Spain
  • H. Clinic I Provincial de Barcelona
    Barcelona, Spain
  • H. de la Santa Creu i Sant Pau
    Barcelona, Spain
  • H. de Basurto
    Bilbao, Spain
  • H. Universitario de Burgos
    Burgos, Spain
  • Complejo Hospitalario de Cáceres
    Cáceres, Spain
  • H. San Pedro de Alcántara
    Cáceres, Spain
  • H. Gral de Ciudad Real
    Ciudad Real, Spain
  • H. Reina Sofía
    Córdoba, Spain
  • H.Universitario Virgen de las Nieves
    Granada, Spain
  • H.Universitario de Guadalajara
    Guadalajara, Spain
  • H. Universitario Insular de las Palmas
    Las Palmas de Gran Canaria, Spain
  • H. De León
    León, 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
    Madrid, Spain
  • H. Clínico Virgen de la Victoria
    Málaga, Spain
  • H. General Universitario Reina Sofía
    Murcia, Spain
  • H. Universitario Virgen de la Arrixaca
    Murcia, Spain
  • H. Son Llátzer
    Palma de Mallorca, Spain
  • H. de Navarra
    Pamplona, Spain
  • H.Universitario Nuestra Señora de Candelaria
    Santa Cruz de Tenerife, Spain
  • H. Universitario Marqués de Valdecilla
    Santander, Spain
  • H. Universitario Nuestra Señora de Valme
    Seville, Spain
  • H. Universitario Virgen Macarena
    Seville, Spain
  • H. Universitario Joan XXIII
    Tarragona, Spain
  • Complejo Hospitalario de Toledo
    Toledo, Spain
  • H. General Universitario de Valencia
    Valencia, Spain
  • H. Universitario la Fe
    Valencia, Spain
  • H. Clínico Universitario de Valladolid
    Valladolid, Spain
  • Complejo Hospitalario Universitario de Vigo
    Vigo, Spain
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01561144
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Responsible party
Sponsor
First posted
Mar 22, 2012
Start date
Aug 2011
Primary completion
Nov 2017
Completion
Nov 2017
Last update
Jul 8, 2025
View the source record on ClinicalTrials.gov ↗

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