Clinical trial NCT01561144: UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator (ICD) Implant
Official title: UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic ICD Implant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiomyopathies
Cardiac Arrhythmias
Cardiac Arrest
Keywords: Defibrillators, Implantable
Cardiac arrhythmias
Heart Disease
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 4648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients inplanted with an Implantable Cardiac Defibrillator (ICD) according to guidelines.

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.

Detailed description: Umbrella is a prospective and retrospective cohort study.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD.
timeFrame: End of the study, an expected duration of 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: H. General Universitario de Elche
state: Alicante
city: Vitoria
country: Spain
facility: H. de Txagorritxu
state: Araba
city: Oviedo
country: Spain
facility: H. Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: H. Universitari Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: H. Universitari de Bellvitge
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario de Santiago
state: Coruña
city: Donostia
country: Spain
facility: Complejo Hospitalario Donostia
state: Guipúzcoa
city: Majadahonda
country: Spain
facility: H. Puerta de Hierro - Majadahonda
state: Madrid
city: Lorca
country: Spain
facility: H. Rafael Méndez
state: Murcia
city: San Cristobal de la Laguna
country: Spain
facility: H. Universitario de Canarias
state: Santa Cruz De Tenerife
city: Alzira
country: Spain
facility: H. Universitario De La Ribera
state: Valencia
city: Barakaldo
country: Spain
facility: H. de Cruces
state: Vizcaya
city: Galdakao
country: Spain
facility: H. Galdakao - Usansolo
state: Vizcaya
city: Alicante
country: Spain
facility: H. General de Alicante
city: Alicante
country: Spain
facility: H. Universitario San Juan de Alicante
city: Almería
country: Spain
facility: Complejo Hospitalario Torrecárdenas de Almería
city: Badajoz
country: Spain
facility: H. Infanta Cristina
city: Barcelona
country: Spain
facility: H. Clinic I Provincial de Barcelona
city: Barcelona
country: Spain
facility: H. de la Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: H. de Basurto
city: Burgos
country: Spain
facility: H. Universitario de Burgos
city: Ciudad Real
country: Spain
facility: H. Gral de Ciudad Real
city: Cáceres
country: Spain
facility: Complejo Hospitalario de Cáceres
city: Cáceres
country: Spain
facility: H. San Pedro de Alcántara
city: Córdoba
country: Spain
facility: H. Reina Sofía
city: Granada
country: Spain
facility: H.Universitario Virgen de las Nieves
city: Guadalajara
country: Spain
facility: H.Universitario de Guadalajara
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: H. Universitario Insular de las Palmas
city: León
country: Spain
facility: H. De León
city: Madrid
country: Spain
facility: H. Clínico San Carlos
city: Madrid
country: Spain
facility: H. Infanta Leonor
city: Madrid
country: Spain
facility: H. Universitario 12 de Octubre
city: Madrid
country: Spain
facility: H. Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: H. Universitario La Paz
city: Madrid
country: Spain
facility: H. Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: H. General Universitario Reina Sofía
city: Murcia
country: Spain
facility: H. Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H. Clínico Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: H. Son Llátzer
city: Pamplona
country: Spain
facility: H. de Navarra
city: Santa Cruz de Tenerife
country: Spain
facility: H.Universitario Nuestra Señora de Candelaria
city: Santander
country: Spain
facility: H. Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: H. Universitario Nuestra Señora de Valme
city: Sevilla
country: Spain
facility: H. Universitario Virgen Macarena
city: Tarragona
country: Spain
facility: H. Universitario Joan XXIII
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: H. General Universitario de Valencia
city: Valencia
country: Spain
facility: H. Universitario la Fe
city: Valladolid
country: Spain
facility: H. Clínico Universitario de Valladolid
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.