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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Heart rhythm measurements with Preventicus®
Heart rhythm measurements with FibriCheck®
Heart rhythm measurements with Apple Watch®
Heart rhythm measurements with 6L Kardia Mobile®
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ziekenhuis Oost-LimburgRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study population (single arm)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 4, 2023
Last Updated
October 19, 2023
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT06023290
Brief Title
Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
Acronym
VALIDATION
Official Title
Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
November 17, 2023 (Anticipated)
Study Completion Date
November 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study population (single arm)
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Heart rhythm measurements with Preventicus®
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Heart rhythm measurements with FibriCheck®
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Heart rhythm measurements with Apple Watch®
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Heart rhythm measurements with 6L Kardia Mobile®
Intervention Description
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 Outcome Measure Information:
Title
Sensitivity
Description
Proportion of true positives tests with the device of interest out of all patients with AF on the 12-lead ECG.
Time Frame
During the heart rhythm measurements
Title
Specificity
Description
Proportion of true negative tests with the device of interest out of all patients in sinus rhythm on the 12-lead ECG.
Time Frame
During the heart rhythm measurements
Title
Accuracy
Description
Proportion of correct classifications with the device of interest. Correct classification is provided by the 12-lead ECG.
Time Frame
During the heart rhythm measurements
Title
Cramer's V
Description
The association of between the classification by the device of interest versus the 12-lead ECG, expressed as Cramer's V.
Time Frame
During the heart rhythm measurements
Secondary Outcome Measure Information:
Title
Positive predictive value
Description
Proportion of true positive tests out of all positive tests.
Time Frame
During the heart rhythm measurements
Title
Negative predictive value
Description
Proportion of true negative tests out of all negative tests.
Time Frame
During the heart rhythm measurements
Title
Patient preference score (for the use of the diagnostic devices)
Description
This score is a (1-5) ordinal result based on the VALIDATION study questionnaire.
Time Frame
During the heart rhythm measurements
Other Pre-specified Outcome Measures:
Title
Sensitivity, specificity and Cramer's V using only measurements of sufficient quality for analysis
Description
The proportion of true positive tests, true negative tests and the association of between the classification of the test devices and 12-lead ECG.
Time Frame
During the heart rhythm measurements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henri M.P.B.C. Gruwez, MD
Phone
+32475223949
Email
henri.gruwez@zol.be
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henri Gruwez, MD
Phone
+32475223949
Email
henri.gruwez@zol.be

12. IPD Sharing Statement

Learn more about this trial

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

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