Graz Study on the Risk of Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk. Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.

Official Title
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Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients

Conditions
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Atrial Fibrillation, Hypertension, Diabetes, Chronic Heart Failure, Vascular Disease

Intervention / Treatment
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* Device: Medtronic Reveal XT implantable loop recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CHA2DS2-VASc risk score >= 4* 18 years or older Exclusion Criteria: known history of atrial fibrillation implanted rhythm device pre-existing indication for oral anticoagulation (*)CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age >= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age >=65 and < 75 years (1 point); Sc - sex category (female) (1 point) ;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: loop recorder<br>patients will be implanted with a subcutaneous loop recorder and have regular follow-ups | Device: Medtronic Reveal XT implantable loop recorder<br>* subcutaneous implantation<br>|
| No Intervention: regular follow-up<br>patients will receive regular follow-ups with standard ECG | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first diagnosis of atrial fibrillation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to change in therapy based on the diagnosis of atrial fibrillation |  | Baseline (0 months), 1,2,3,4,5,6,9 and 12 months | 
| Hospitalizations |  | 12 months | 
| Change in NTproBNP serum level associated with occurrence of atrial fibrillation |  | Baseline (0 months), 1,2,3,4,5,6,9 and 12 months | 
| Death |  | 12 months | 
| Stroke |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, biomarkers, stroke prevention, implantable loop recorder