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NCT01561144 Clinical Trial

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

Cardiac Arrest Clinical Trial

— UMBRELLA  

Official title:
UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic ICD Implant

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01561144
Other study ID # UMBRELLA
Secondary ID
Status Terminated
Phase N/A
First received March 16, 2012
Last updated January 29, 2018
Start date August 2011
Est. completion date November 2017

Study information
Verified date January 2018
Source Medtronic Bakken Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Description:

Umbrella is a prospective and retrospective cohort study.

Recruitment information / eligibility
Status Terminated
Enrollment 4648
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Spain H. General de Alicante Alicante
Spain H. Universitario San Juan de Alicante Alicante
Spain Complejo Hospitalario Torrecárdenas de Almería Almería
Spain H. Universitario De La Ribera Alzira Valencia
Spain H. Infanta Cristina Badajoz
Spain H. Universitari Germans Trias i Pujol Badalona Barcelona
Spain H. de Cruces Barakaldo Vizcaya
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 Complejo Hospitalario Donostia Donostia Guipúzcoa
Spain H. General Universitario de Elche Elche Alicante
Spain H. Galdakao - Usansolo Galdakao Vizcaya
Spain H.Universitario Virgen de las Nieves Granada
Spain H.Universitario de Guadalajara Guadalajara
Spain H. Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
Spain Complejo Hospitalario Universitario A Coruña La Coruña
Spain H. Universitario Insular de las Palmas Las Palmas de Gran Canaria
Spain H. De León León
Spain H. Rafael Méndez Lorca Murcia
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. Puerta de Hierro - Majadahonda Majadahonda 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. Universitario Central de Asturias Oviedo Asturias
Spain H. Son Llátzer Palma de Mallorca
Spain H. de Navarra Pamplona
Spain H. Universitario de Canarias San Cristobal de la Laguna Santa Cruz De Tenerife
Spain H.Universitario Nuestra Señora de Candelaria Santa Cruz de Tenerife
Spain H. Universitario Marqués de Valdecilla Santander
Spain Complejo Hospitalario de Santiago Santiago de Compostela Coruña
Spain H. Universitario Nuestra Señora de Valme Sevilla
Spain H. Universitario Virgen Macarena Sevilla
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 H. de Txagorritxu Vitoria Araba

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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