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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: Heart rhythm measurements with Preventicus®; Diagnostic Test: Heart rhythm measurements with FibriCheck®; Diagnostic Test: Heart rhythm measurements with Apple Watch®; Diagnostic Test: Heart rhythm measurements with 6L Kardia Mobile®

• Registration Number: NCT06023290
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-03
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-05
• Primary Completion: 2023-10-27
• Status Verified: 2023-11
• Study Completion: 2023-11-17
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population (single arm)	Heart rhythm measurements with FibriCheck®	-
Study population (single arm)	Heart rhythm measurements with Apple Watch®	-
Study population (single arm)	Heart rhythm measurements with Preventicus®	-
Study population (single arm)	Heart rhythm measurements with 6L Kardia Mobile®	-

Primary Outcome Measures

Name	Time	Method
Cramer's V	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.
Sensitivity	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.
Accuracy	During the heart rhythm measurements	Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
Specificity	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.

Secondary Outcome Measures

Name	Time	Method
Negative predictive value	During the heart rhythm measurements	Proportion of true negative tests out of all negative tests.
Patient preference score (for the use of the diagnostic devices)	During the heart rhythm measurements	This score is a (1-5) ordinal result based on the VALIDATION study questionnaire.
Positive predictive value	During the heart rhythm measurements	Proportion of true positive tests out of all positive tests.

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium