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Completed

NCT Number: NCT06023290

Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation

The VALIDATION study aims to evaluate the performance of four state-of-the-art digital heart rhythm devices (Preventicus®, FibriCheck®, Apple Watch®, 6L Kardia Mobile®) for the detection of atrial fibrillation.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is an ambulatory cardiology patient.
  • The patient is at least 18 years old.
  • The patient is sinus or in atrial fibrillation.
  • The patient is able to perform the study procedures together with the study assistant.

Exclusion criteria

  • Patients with a pacemaker
  • Inclusion in another clinical trial that may influence the results of this trial
  • The patient is unable to comprehend the informed consent.

Treatment and study plan

Heart rhythm measurements with Preventicus®

Diagnostic Test

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

Heart rhythm measurements with FibriCheck®

Diagnostic Test

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

Heart rhythm measurements with Apple Watch®

Diagnostic Test

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

Heart rhythm measurements with 6L Kardia Mobile®

Diagnostic Test

The sequence of the digital heart rhythm measurements is randomly assigned for each patient. The reference heart rhythm is determined by a simultaneous recording with a 12-lead ECG as gold standard.

Primary outcomes

  1. Sensitivity

    Time frame: During the heart rhythm measurements

    Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.

  2. Specificity

    Time frame: During the heart rhythm measurements

    Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.

  3. Accuracy

    Time frame: During the heart rhythm measurements

    Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.

  4. Cramer's V

    Time frame: During the heart rhythm measurements

    The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.

Secondary outcomes

  1. Positive predictive value

    Time frame: During the heart rhythm measurements

    Proportion of true positive tests out of all positive tests.

  2. Negative predictive value

    Time frame: During the heart rhythm measurements

    Proportion of true negative tests out of all negative tests.

  3. Patient preference score (for the use of the diagnostic devices)

    Time frame: During the heart rhythm measurements

    This score is a (1-5) ordinal result based on the VALIDATION study questionnaire.

Other outcomes

  1. Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis

    Time frame: During the heart rhythm measurements

    The proportion of true positive tests, true negative tests and the association of between the classification of the test devices and 12-lead ECG.

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Acronym: VALIDATION

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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