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

Not Applicable

Completed

• Conditions: Arterial Hypertension; Diabetes Mellitus
• Interventions: Device: Implantable loop recorder; Other: Conventional Holter monitoring

• Registration Number: NCT02041832
• Lead Sponsor: Axel Brandes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2014-01-18
• Study First Posted: 2014-01-22
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Implantable loop recorder	Implantable loop recorder	Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder
Holter monitoring	Conventional Holter monitoring	Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring

Primary Outcome Measures

Name	Time	Method
First episode of atrial fibrillation	1 year

Secondary Outcome Measures

Name	Time	Method
Correlation between echocardiographic parameters and incidence of atrial fibrillation	1 year

Trial Locations

Locations (1)

Haderslev Hospital; 🇩🇰 Haderslev, Denmark