Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06023290
Other study ID # Z-2023023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A