Atrial Fibrillation Detected by Continuous ECG Monitoring "LOOP"

Recruiting

Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

To be eligible for the study subjects must fulfil the following criteria at inclusion:
- Living address in Region Zealand, Region of Southern Denmark or the Capital Region of Denmark (study subjects from other regions of Denmark who actively contact the study for participation can be included if they wish to participate)
- 70-90 years of age at the time of screening and in addition the study subject should be clinically evaluated to be biologically a potential candidate for anti-coagulation therapy
and additionally have at least one of the diseases mentioned below:
- Known diabetes mellitus (type 1 or type 2, with or without medical therapy)
- History with hypertension with or without a therapy that may reduce blood pressure (i.e., an increased blood pressure at randomization is not required)
- Heart failure: New York Heart Association (NYHA) class II-IV or a reduced left ventricular ejection fraction (< 0.50).
- Previous diagnosed stroke (preferably diagnosed in hospital and verified by imaging; previous (TIA, transitory ischemic attack, is not considered an inclusion criterion; a specific time interval from previous stroke to inclusion time is not required) Concerning the four qualifying diseases the study subject is considered qualified for study inclusion if he has a history of one of the diseases (for example subject is now normotensive on life-style correction or medical therapy and similarly if blood glucose has been normalised upon life-style corrections or medical therapy).

Exclusion Criteria

- Uncorrected, congenital heart disease or severe valvular stenosis, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis.
- Recipient of any major organ transplant (e.g. lung, liver, heart or kidney)
- Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 months before randomization or clinical evidence of current malignancy with the following exceptions: Basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable, localized disease with a life expectancy of > 2.5 years in the opinion of the investigator)
- Known to be human immunodeficiency virus (HIV) positive with an expected survival of less than 5 years due to HIV infection
- Renal failure treated with permanent dialysis
- Recent (within 3 months) history of alcohol or drug abuse based on self-reporting
- Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study
- Known atrial fibrillation irrespective of its type (paroxysmal, persistent, long-lasting persistent or permanent)
- Ongoing therapy with OAC or newer OAC (whereas therapy with platelet inhibitors such as acetyl-salicylic acid, clopidogrel, persantine is not considered as an exclusion)
- Patients who have a pacemaker (including cardiac resynchronization therapy-pacemaker, CRT-P) or implantable cardioverter defibrillator (ICD), including a Cardiac Resynchronization Therapy defibrillator (CRT-D)
- Existing contraindication to oral anticoagulation (OAC) therapy
- On a waiting list for major surgery (cardiac, thoracic or abdominal)
- Cardiac or thoracic surgery has been performed within 3 months from inclusion
- Life-expectancy shorter than 6 months
- Unwillingness to participate or patient does not understand Danish language