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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medtronic Bakken Research Center
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

Resource links provided by NLM:


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
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

Contacts
Contact: Alicia Cano +34 91 6250518 alicia.cano@medtronic.com
Contact: María Garcia +34 91 6346218 maria_m.garcia@medtronic.com

Locations
Spain
H. General Universitario de Elche Recruiting
Elche, Alicante, Spain
H. de Txagorritxu Recruiting
Vitoria, Araba, Spain
H. Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain
H. Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain
H. Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Donostia Recruiting
Donostia, Guipúzcoa, Spain
H. Puerta de Hierro - Majadahonda Recruiting
Majadahonda, Madrid, Spain
H. Universitario de Canarias Recruiting
San Cristobal de la Laguna, Santa Cruz de Tenerife, Spain
H. de Cruces Recruiting
Barakaldo, Vizcaya, Spain
H. Galdakao - Usansolo Recruiting
Galdakao, Vizcaya, Spain
H. Universitario San Juan de Alicante Recruiting
Alicante, Spain
H. General de Alicante Recruiting
Alicante, Spain
Complejo Hospitalario Torrecárdenas de Almería Recruiting
Almería, Spain
H. Infanta Cristina Recruiting
Badajoz, Spain
H. de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
H. Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain
H. de Basurto Recruiting
Bilbao, Spain
H. Universitario de Burgos Recruiting
Burgos, Spain
H. Gral de Ciudad Real Recruiting
Ciudad Real, Spain
H. San Pedro de Alcántara Recruiting
Cáceres, Spain
H.Universitario Virgen de las Nieves Recruiting
Granada, Spain
H.Universitario de Guadalajara Recruiting
Guadalajara, Spain
Complejo Hospitalario Universitario A Coruña Recruiting
La Coruña, Spain
H. Universitario Insular de las Palmas Recruiting
Las Palmas de Gran Canaria, Spain
H. Clínico San Carlos Recruiting
Madrid, Spain
H. Infanta Leonor Recruiting
Madrid, Spain
H. Universitario 12 de Octubre Recruiting
Madrid, Spain
H. Universitario Gregorio Marañón Recruiting
Madrid, Spain
H. Universitario La Paz Recruiting
Madrid, Spain
H. General Universitario Reina Sofía Recruiting
Murcia, Spain
H. Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain
H. Clínico Virgen de la Victoria Recruiting
Málaga, Spain
H. Son Llátzer Recruiting
Palma de Mallorca, Spain
H. de Navarra Recruiting
Pamplona, Spain
H.Universitario Nuestra Señora de Candelaria Recruiting
Santa Cruz de Tenerife, Spain
H. Universitario Nuestra Señora de Valme Recruiting
Sevilla, Spain
H. Universitario Virgen Macarena Recruiting
Sevilla, Spain
H. Universitario Joan XXIII Recruiting
Tarragona, Spain
H. Universitario la Fe Recruiting
Valencia, Spain
H. General Universitario de Valencia Recruiting
Valencia, Spain
H. Clínico Universitario de Valladolid Recruiting
Valladolid, Spain
Complejo Hospitalario Universitario de Vigo Recruiting
Vigo, Spain
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

No publications provided

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:
Arrhythmias, Cardiac
Heart Arrest
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014