Back to resultsDIGITAL fOllow uP for aTrial fIbrillation After pulMonary veIn iSolaTion (DIGITAL OPTIMIST)
Primary Purpose
Atrial Fibrillation, Atrial Fibrillation Recurrent, PVI
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Digital Monitoring
Standard of care
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, PVI, Atrial ablation, pulmonary vein isolation, PPG, Photoplethysmography, Digital Health
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.
Sites / Locations
- Ziekenhuis Oost-LimburgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
All subjects will receive both standard of care monitoring and digital rhythm monitoring using a PPG based smartphone application for AF recurrence after the PVI procedure.
Outcomes
Primary Outcome Measures
AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation
Secondary Outcome Measures
Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.
The number and dispersion of PPG measurements needed to achieve similar sensitivity with intermittent one-minute PPG measurements compared to one 24h-Holter.
Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.
Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.
Predictive value of AF detection with PPG during blanking period for AF recurrence.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05486364
Brief Title
DIGITAL fOllow uP for aTrial fIbrillation After pulMonary veIn iSolaTion (DIGITAL OPTIMIST)
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 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation (PVI) procedure is frequent. Current follow up with Holter monitoring and electrocardiograms (ECG) during outpatient clinic consultations cover only short time stretches and require hospital visits. Mobile health solutions with rhythm monitoring using photoplethysmography (PPG) technology on a smartphone could extend rhythm monitoring time, while lowering hospital visits and cost. This study aims to compare the performance of a digital health solution using PPG technology on a smartphone versus the current standard of care to monitor for AF recurrence after a PVI procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Fibrillation Recurrent, PVI
Keywords
Atrial Fibrillation, PVI, Atrial ablation, pulmonary vein isolation, PPG, Photoplethysmography, 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
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
All subjects will receive both standard of care monitoring and digital rhythm monitoring using a PPG based smartphone application for AF recurrence after the PVI procedure.
Intervention Type
Diagnostic Test
Intervention Name(s)
Digital Monitoring
Intervention Description
Subjects will perform self-measurements with a PPG based smartphone application (FibriCheck™) to monitor for AF recurrence after the PVI procedure. One-minute measurements will be performed twice daily starting one month before the PVI procedure and continue up to 12 months after the procedure.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard of care
Intervention Description
Subjects will wear a 24-hour holter monitor at 3, 6 and 12 months after the PVI procedure. Additionally, outpatient cardiology clinic visits are organised at 6 weeks, 3 months and 12 months after the PVI procedure (including a 12-lead ECG and cardiologist consultation).
Primary Outcome Measure Information:
Title
AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.
Time Frame
1 year
Title
The number and dispersion of PPG measurements needed to achieve similar sensitivity with intermittent one-minute PPG measurements compared to one 24h-Holter.
Time Frame
1 year
Title
Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.
Time Frame
1 year
Title
Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.
Time Frame
1 year
Title
Predictive value of AF detection with PPG during blanking period for AF recurrence.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Patient compliance with PPG measurements
Time Frame
1 year
Title
Evaluation of AF-burden quantification by intermittent PPG measurements.
Time Frame
1 year
Title
Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3
Description
Excluding ECG measurements that were triggered by AF detection with PPG.
Time Frame
1 year
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
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evi Theunis
Email
evi.theunis@zol.be
12. IPD Sharing Statement
Learn more about this trial
DIGITAL fOllow uP for aTrial fIbrillation After pulMonary veIn iSolaTion (DIGITAL OPTIMIST)
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