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

• Sponsor: Ziekenhuis Oost-Limburg (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06023290
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 1.9
• Patients Per Site Per Month: 77.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	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®	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
• Actual Study Start Date: Jul 3, 2023
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. Accuracy [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 [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 Outcome Measures

1. Positive predictive value [During the heart rhythm measurements]

2. 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.

Other Outcome Measures

1. Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis [During the heart rhythm measurements]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziekenhuis Oost-Limburg	Genk	Limburg	Belgium	3600

Sponsors and Collaborators

• Ziekenhuis Oost-Limburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziekenhuis Oost-Limburg
• ClinicalTrials.gov Identifier: NCT06023290
• Other Study ID Numbers: Z-2023023
• First Posted: Sep 5, 2023
• Last Update Posted: Sep 5, 2023
• Last Verified: Jul 1, 2023

• 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
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Sep 5, 2023