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

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Heart rhythm measurements with FibriCheck®
Heart rhythm measurements with 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 focused on measuring Atrial Fibrillation, Photoplethysmography, Single-lead ECG, Electrocardiogram, Digital Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ziekenhuis Oost-LimburgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT06028893
Brief Title
DIGITAL fOllow uP for aTrial fIbrillation After pulMonary veIn iSolaTion (DIGITAL OPTIMIST - 2)
Official Title
A Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Detection of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 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
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Photoplethysmography, Single-lead ECG, Electrocardiogram, Digital Health

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
All subjects will perform heart rhythm measurements with both diagnostic tests.
Intervention Type
Diagnostic Test
Intervention Name(s)
Heart rhythm measurements with FibriCheck®
Intervention Description
Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Heart rhythm measurements with Kardia Mobile®
Intervention Description
Measurements are performed immediately before and after every FibriCheck® measurement.
Primary Outcome Measure Information:
Title
Sensitivity
Description
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Time Frame
Two months
Title
Specificity
Description
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Time Frame
Two months
Title
Accuracy
Description
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Positive predictive value
Description
Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Time Frame
Two months
Title
Negative predictive value
Description
Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Time Frame
Two months
Title
Sensitivity by heart rate interval
Description
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Time Frame
Two months
Title
Specificity by heart rate interval
Description
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Time Frame
Two months
Title
Accuracy by heart rate interval
Description
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Time Frame
Two months
Title
Proportion of PPG measurements of insufficient quality for rhythm analysis
Description
PPG measurements by FibriCheck®.
Time Frame
Two months
Title
Proportion of ECG measurements of insufficient quality for rhythm analysis
Description
ECG measurements by Kardia Mobile®.
Time Frame
Two months
Title
Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval
Description
PPG measurements by FibriCheck®.
Time Frame
Two months
Title
Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval
Description
ECG measurements by Kardia Mobile®.
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henri Gruwez, MD
Phone
+3289212051
Email
henri.gruwez@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Pison, MD, PhD
Email
laurent.pison@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
+3289212051
Email
henri.gruwez@zol.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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