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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01561144

Acronym

UMBRELLA

Enrollment

4648

Registered

2012-03-22

Start date

2011-08-31

Completion date

2017-11-30

Last updated

2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Cardiac Arrhythmias, Cardiomyopathies

Keywords

Defibrillators, Implantable, Cardiac arrhythmias, Heart Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.

Countries

Spain

Outcome results