Validation of Digital Heart Rhythm Devices in the Detection of Atrial Fibrillation
NCT ID: NCT06023290
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2023-07-03
2023-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Study population (single arm)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inclusion in another clinical trial that may influence the results of this trial
* The patient is unable to comprehend the informed consent.
18 Years
ALL
Yes
Sponsors
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Ziekenhuis Oost-Limburg
OTHER
Responsible Party
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Locations
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Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Countries
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Other Identifiers
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Z-2023023
Identifier Type: -
Identifier Source: org_study_id