DIGITAL fOllow uP for aTrial fIbrillation After pulMonary veIn iSolaTion (DIGITAL OPTIMIST - 2)

Sponsor

Ziekenhuis Oost-Limburg (Other)

Overall Status

Recruiting

CT.gov ID

NCT06028893

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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®).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Diagnostic Test: Heart rhythm measurements with FibriCheck® Diagnostic Test: Heart rhythm measurements with Kardia Mobile®	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Detection of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group All subjects will perform heart rhythm measurements with both diagnostic tests.	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. Diagnostic Test: Heart rhythm measurements with Kardia Mobile® Measurements are performed immediately before and after every FibriCheck® measurement.

Arm

Intervention/Treatment

Experimental: Study group

All subjects will perform heart rhythm measurements with both diagnostic tests.

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.

Diagnostic Test: Heart rhythm measurements with Kardia Mobile®

Measurements are performed immediately before and after every FibriCheck® measurement.

Outcome Measures

Primary Outcome Measures

Sensitivity [Two months]
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Specificity [Two months]
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Accuracy [Two months]
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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:

NCT06028893

Other Study ID Numbers:

Z-2021058-2

First Posted:

Sep 8, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Ziekenhuis Oost-Limburg

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Sep 8, 2023