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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02041832
Other study ID # ILR-Afib-study
Secondary ID S-20130062
Status Completed
Phase N/A
First received November 28, 2013
Last updated September 27, 2016
Start date October 2013
Est. completion date September 2016

Study information

Verified date September 2016
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines Authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 90 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Other:
Conventional Holter monitoring
Patients undergo 72h Holter monitoring
Device:
Implantable loop recorder
Implantation of loop recorder with follow-up by remote monitoring

Locations

Country Name City State
Denmark Haderslev Hospital Haderslev

Sponsors (1)

Lead Sponsor Collaborator
Axel Brandes

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Correlation between biomarkers and incidence of atrial fibrillation 1 year No
Primary First episode of atrial fibrillation 1 year No
Secondary Correlation between echocardiographic parameters and incidence of atrial fibrillation 1 year No
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