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

Atrial Fibrillation Clinical Trial

— VALIDATION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06023290
• Other study ID #: Z-2023023
• Status: Completed
• Phase: N/A
• Start date: July 3, 2023
• Est. completion date: November 17, 2023

Study information

• Verified date: November 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 17, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	Accuracy	Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.	During the heart rhythm measurements
Primary	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	Positive predictive value	Proportion of true positive tests out of all positive tests.	During the heart rhythm measurements
Secondary	Negative predictive value	Proportion of true negative tests out of all negative tests.	During the heart rhythm measurements
Secondary	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