Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06028893
Other study ID # Z-2021058-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date August 31, 2023

Study information

Verified date August 2023
Source Ziekenhuis Oost-Limburg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion. - Subject provides informed consent. - Subject understands and agrees to comply with planned study procedures. - Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home. Exclusion Criteria: - Insufficient cognitive or comprehensive level of Dutch to participate to the trial. - No access to a smartphone or unable to perform FibriCheck measurements at home. - Pacemaker.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Heart rhythm measurements with FibriCheck®
Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
Heart rhythm measurements with Kardia Mobile®
Measurements are performed immediately before and after every FibriCheck® measurement.

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
Primary Sensitivity Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®. Two months
Primary Specificity Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®. Two months
Primary Overall accuracy (proportion of correct classifications) Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®. Two months
Secondary Positive predictive value Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®. Two months
Secondary Negative predictive value Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®. Two months
Secondary Sensitivity by heart rate interval Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®. Two months
Secondary Specificity by heart rate interval Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®. Two months
Secondary Accuracy by heart rate interval Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®. Two months
Secondary Proportion of PPG measurements of insufficient quality for rhythm analysis PPG measurements by FibriCheck®. Two months
Secondary Proportion of ECG measurements of insufficient quality for rhythm analysis ECG measurements by Kardia Mobile®. Two months
Secondary Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval PPG measurements by FibriCheck®. Two months
Secondary Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval ECG measurements by Kardia Mobile®. Two months
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