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OpenTrials
Completed

NCT Number: NCT02041832

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

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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haderslev Hospital

Haderslev, 6100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Holter monitoring

Other

Patients undergo 72h Holter monitoring

Implantable Loop Recorder

Device

Implantation of loop recorder with follow-up by remote monitoring

Other names: REVEAL XT

Primary outcomes

  1. First episode of atrial fibrillation

    Time frame: 1 year

Secondary outcomes

  1. Correlation between echocardiographic parameters and incidence of atrial fibrillation

    Time frame: 1 year

Other outcomes

  1. Correlation between biomarkers and incidence of atrial fibrillation

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Axel Brandes

Other

Registry information

Official study title

Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2014
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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