Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation (VALIDATION)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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®

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Study population (single arm)

Diagnostic test: Heart rhythm measurements with Preventicus®; 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.; Diagnostic test: Heart rhythm measurements with FibriCheck®; 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.; Diagnostic test: Heart rhythm measurements with Apple Watch®; 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.; Diagnostic test: Heart rhythm measurements with 6L Kardia Mobile®; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.	During the heart rhythm measurements
Specificity	Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.	During the heart rhythm measurements
Accuracy	Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.	During the heart rhythm measurements
Cramer's V	The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.	During the heart rhythm measurements

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis	The proportion of true positive tests, true negative tests and the association of between the classification of the test devices and 12-lead ECG.	During the heart rhythm measurements

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Z-2023023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No