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

NCT ID: NCT01561144

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4648 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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Umbrella is a prospective and retrospective cohort study.

Conditions

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Cardiomyopathies Cardiac Arrhythmias Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H. General Universitario de Elche

Elche, Alicante, Spain

Site Status

H. de Txagorritxu

Vitoria-Gasteiz, Araba, Spain

Site Status

H. Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

H. Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Complejo Hospitalario de Santiago

Santiago de Compostela, Coruña, Spain

Site Status

Complejo Hospitalario Donostia

Donostia / San Sebastian, Guipúzcoa, Spain

Site Status

H. Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Site Status

H. Rafael Méndez

Lorca, Murcia, Spain

Site Status

H. Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

H. Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Site Status

H. Universitario De La Ribera

Alzira, Valencia, Spain

Site Status

H. de Cruces

Barakaldo, Vizcaya, Spain

Site Status

H. Galdakao - Usansolo

Galdakao, Vizcaya, Spain

Site Status

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status

H. General de Alicante

Alicante, , Spain

Site Status

H. Universitario San Juan de Alicante

Alicante, , Spain

Site Status

Complejo Hospitalario Torrecárdenas de Almería

Almería, , Spain

Site Status

H. Infanta Cristina

Badajoz, , Spain

Site Status

H. Clinic I Provincial de Barcelona

Barcelona, , Spain

Site Status

H. de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

H. de Basurto

Bilbao, , Spain

Site Status

H. Universitario de Burgos

Burgos, , Spain

Site Status

Complejo Hospitalario de Cáceres

Cáceres, , Spain

Site Status

H. San Pedro de Alcántara

Cáceres, , Spain

Site Status

H. Gral de Ciudad Real

Ciudad Real, , Spain

Site Status

H. Reina Sofía

Córdoba, , Spain

Site Status

H.Universitario Virgen de las Nieves

Granada, , Spain

Site Status

H.Universitario de Guadalajara

Guadalajara, , Spain

Site Status

H. Universitario Insular de las Palmas

Las Palmas de Gran Canaria, , Spain

Site Status

H. De León

León, , Spain

Site Status

H. Clínico San Carlos

Madrid, , Spain

Site Status

H. Infanta Leonor

Madrid, , Spain

Site Status

H. Universitario 12 de Octubre

Madrid, , Spain

Site Status

H. Universitario Gregorio Marañón

Madrid, , Spain

Site Status

H. Universitario La Paz

Madrid, , Spain

Site Status

H. Universitario Ramón y Cajal

Madrid, , Spain

Site Status

H. Clínico Virgen de la Victoria

Málaga, , Spain

Site Status

H. General Universitario Reina Sofía

Murcia, , Spain

Site Status

H. Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status

H. Son Llátzer

Palma de Mallorca, , Spain

Site Status

H. de Navarra

Pamplona, , Spain

Site Status

H.Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

H. Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

H. Universitario Nuestra Señora de Valme

Seville, , Spain

Site Status

H. Universitario Virgen Macarena

Seville, , Spain

Site Status

H. Universitario Joan XXIII

Tarragona, , Spain

Site Status

Complejo Hospitalario de Toledo

Toledo, , Spain

Site Status

H. General Universitario de Valencia

Valencia, , Spain

Site Status

H. Universitario la Fe

Valencia, , Spain

Site Status

H. Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33356406 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32773348 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27296239 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25916814 (View on PubMed)

Other Identifiers

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UMBRELLA

Identifier Type: -

Identifier Source: org_study_id

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