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

Terminated

• Conditions: Cardiac Arrest; Cardiomyopathies; Cardiac Arrhythmias

• Registration Number: NCT01561144
• Lead Sponsor: Medtronic Bakken Research Center

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4648

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (51)

H. Rafael Méndez; 🇪🇸 Lorca, Murcia, Spain

H. de Basurto; 🇪🇸 Bilbao, Spain

H. Universitario Insular de las Palmas; 🇪🇸 Las Palmas de Gran Canaria, Spain

H. Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

H. Reina Sofía; 🇪🇸 Córdoba, Spain

H.Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

H. Puerta de Hierro - Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

H. Gral de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Complejo Hospitalario de Cáceres; 🇪🇸 Cáceres, Spain

H. General de Alicante; 🇪🇸 Alicante, Spain

Complejo Hospitalario Torrecárdenas de Almería; 🇪🇸 Almería, Spain

H. Galdakao - Usansolo; 🇪🇸 Galdakao, Vizcaya, Spain

H. Clinic I Provincial de Barcelona; 🇪🇸 Barcelona, Spain

H.Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

H. de Navarra; 🇪🇸 Pamplona, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 La Coruña, Spain

H. Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

H. Infanta Leonor; 🇪🇸 Madrid, Spain

H. Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

H. De León; 🇪🇸 León, Spain

H. de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

H. General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Complejo Hospitalario Donostia; 🇪🇸 Donostia, Guipúzcoa, Spain

H. de Cruces; 🇪🇸 Barakaldo, Vizcaya, Spain

H. Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

H. Universitario San Juan de Alicante; 🇪🇸 Alicante, Spain

H. Infanta Cristina; 🇪🇸 Badajoz, Spain

H. Clínico San Carlos; 🇪🇸 Madrid, Spain

H. Universitario Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain

H.Universitario Nuestra Señora de Candelaria; 🇪🇸 Santa Cruz de Tenerife, Spain

H. Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

H. Universitario La Paz; 🇪🇸 Madrid, Spain

H. Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

H. San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain

H. Universitario de Canarias; 🇪🇸 San Cristobal de la Laguna, Santa Cruz De Tenerife, Spain

H. Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

H. Son Llátzer; 🇪🇸 Palma de Mallorca, Spain

H. General Universitario de Valencia; 🇪🇸 Valencia, Spain

H. Universitario la Fe; 🇪🇸 Valencia, Spain

H. Clínico Virgen de la Victoria; 🇪🇸 Málaga, Spain

H. Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

H. Universitario Joan XXIII; 🇪🇸 Tarragona, Spain

H. Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

H. de Txagorritxu; 🇪🇸 Vitoria, Araba, Spain

H. Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

H. Universitario De La Ribera; 🇪🇸 Alzira, Valencia, Spain

Complejo Hospitalario de Santiago; 🇪🇸 Santiago de Compostela, Coruña, Spain

H. Universitario de Burgos; 🇪🇸 Burgos, Spain

H. General Universitario Reina Sofía; 🇪🇸 Murcia, Spain

Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Spain