Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder

N/ACompletedNCT02041832

Axel Brandes82 enrolled

Overview

Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Arterial Hypertension Diabetes Mellitus

Interventions

Conventional Holter monitoringOTHER

Patients undergo 72h Holter monitoring

Implantable loop recorderDEVICE

Implantation of loop recorder with follow-up by remote monitoring

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \> 65 years * arterial hypertension (at least dual treatment) * diabetes mellitus (oral antidiabetics or insulin) Exclusion Criteria: * known atrial fibrillation * ischaemic heart disease * Current anticoagulation treatment * Ejection fraction \<45 % * significant valvular heart disease * previous stroke/transient ischemic attack * peripheral arterial disease * end stage renal disease * thyreotoxicosis

Locations (1)

Haderslev Hospital

Haderslev, Denmark

Outcomes

Primary Outcomes

First episode of atrial fibrillation

Time frame: 1 year

Secondary Outcomes

Correlation between echocardiographic parameters and incidence of atrial fibrillation

Time frame: 1 year

Data from ClinicalTrials.gov

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