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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Medtronic Bakken Research Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01561144
First received: March 16, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose
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.

Condition
Cardiomyopathies
Cardiac Arrhythmias
Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic ICD Implant

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • To assess the number of ventricular and atrial arrhythmias, and atrial fibrillation burden detected by ICD. [ Time Frame: End of the study, an expected duration of 5 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: August 2011
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Detailed Description:
Umbrella is a prospective and retrospective cohort study.
  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients inplanted with an Implantable Cardiac Defibrillator (ICD) according to guidelines.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561144

Locations
Spain
H. General Universitario de Elche
Elche, Alicante, Spain
H. de Txagorritxu
Vitoria, Araba, Spain
H. Universitario Central de Asturias
Oviedo, Asturias, Spain
H. Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
H. Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Donostia
Donostia, Guipúzcoa, Spain
H. Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
H. Universitario de Canarias
San Cristobal de la Laguna, Santa Cruz de Tenerife, Spain
H. de Cruces
Barakaldo, Vizcaya, Spain
H. Galdakao - Usansolo
Galdakao, Vizcaya, 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
H. Gral de Ciudad Real
Ciudad Real, Spain
H. San Pedro de Alcántara
Cáceres, Spain
H.Universitario Virgen de las Nieves
Granada, Spain
H.Universitario de Guadalajara
Guadalajara, Spain
Complejo Hospitalario Universitario A Coruña
La Coruña, Spain
H. Universitario Insular de las Palmas
Las Palmas de Gran Canaria, 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. General Universitario Reina Sofía
Murcia, Spain
H. Universitario Virgen de la Arrixaca
Murcia, Spain
H. Clínico Virgen de la Victoria
Málaga, 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 Nuestra Señora de Valme
Sevilla, Spain
H. Universitario Virgen Macarena
Sevilla, Spain
H. Universitario Joan XXIII
Tarragona, 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
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01561144     History of Changes
Other Study ID Numbers: UMBRELLA 
Study First Received: March 16, 2012
Last Updated: April 8, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Medtronic Bakken Research Center:
Defibrillators, Implantable
Cardiac arrhythmias
Heart Disease

Additional relevant MeSH terms:
Heart Arrest
Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016