UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator (ICD) Implant
UMBRELLA
1 other identifier
observational
4,648
1 country
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
Longer than P75 for all trials
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJuly 8, 2025
June 1, 2025
6.3 years
March 16, 2012
July 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD.
End of the study, an expected duration of 5 years.
Eligibility Criteria
Patients inplanted with an Implantable Cardiac Defibrillator (ICD) according to guidelines.
You may qualify if:
- Patients with a Medtronic Implantable Cardiac Defibrillator (ICD) according to guidelines.
- Patients with CareLink home Telemonitoring System.
You may not qualify if:
- Unwillingness or inability to sign study written informed consent and/or CareLink consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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
Related Publications (4)
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.
PMID: 33356406DERIVEDLoughlin 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.
PMID: 32773348DERIVEDLillo-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.
PMID: 27296239DERIVEDAnguera 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.
PMID: 25916814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2012
First Posted
March 22, 2012
Study Start
August 1, 2011
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
July 8, 2025
Record last verified: 2025-06