Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement

Study Overview
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Brief Summary
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The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

Detailed Description
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The investigators will assess the performance of an in vitro diagnostic device for assessing the INR. The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value. The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR. A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.

Official Title
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Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)

Conditions
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Healthy, Heart Valves, Arrhythmias, Cardiac, Thromboembolism

Intervention / Treatment
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* Device: Self testing INR device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with vitamin K agonist or healthy volunteers For healthy volunteers : Body Mass index between 18 ans 29 kg/m² No acute disease in the previous month Exclusion Criteria: Pregnant woman

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of the device perfomance<br> | Device: Self testing INR device<br>* the procedure involves a series of repeated measurements of INR with the studied device<br>* Other names: In vitro diagnostic device measuring INR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of measurement of the INR with the study device | The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample. | Just after the blood taken at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of measurement of the INR with the study device | Comparison of 8 INR measurements performed with the device in a range of 15 minutes. | Just after the blood taken at day 1 | 
| Reproductibility of measurement of the INR with the study device | Comparison of 8 INR measurements performed with the device in a range of 15 minutes. The modified parameters between measurements will be the lot of consumables and the study device | Just after the blood taken at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INR, coagulation, vitamin K antagonist