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

September 27, 2016 updated by: Axel Brandes

Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Haderslev, Denmark, 6100
        • Haderslev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Holter monitoring
Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring
Other: Conventional Holter monitoring
Patients undergo 72h Holter monitoring
OTHER: Implantable loop recorder
Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder
Device: Implantable loop recorder
Implantation of loop recorder with follow-up by remote monitoring
Other Names:
  • REVEAL XT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First episode of atrial fibrillation
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between echocardiographic parameters and incidence of atrial fibrillation
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Correlation between biomarkers and incidence of atrial fibrillation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axel Brandes

Investigators

  • Study Director: Axel Brandes, Assoc. Prof., Odense University Hospital/University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

January 18, 2014

First Posted (ESTIMATE)

January 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILR-Afib-study
  • S-20130062 (OTHER: Videnskabsetisk Komité for Region Syddanmark)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Conventional Holter monitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe