Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation
NCT ID: NCT02949180
Last Updated: 2017-12-13
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
672 participants
OBSERVATIONAL
2016-10-31
2017-11-30
Brief Summary
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Detailed Description
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Study design Prospective, blinded, multicenter international trial.
Methods
The subjects will be asked to position a smartphone on their index finger to allow their pulse curve to be recorded for five minutes. At the same time, an ecg will be recorded using an digital mobile ecg recorder as a reference.
Data will be collected on person-related information, comorbidities and medication (estimated overall duration/patient \<20 min). No follow-up is planned. Analogous to predecessor studies, the pulse wave curve data are coded with the patient's identification number (ID) and externally analyzed at Preventicus; based on the results, the subjects will be assigned to SR/AF groups. After evaluation of all files, the grouped results will be aggregated, unblinded and evaluated under monitoring.
Primary target parameters are the app's sensitivity and specificity in correctly detecting atrial fibrillation compared to an automatically interpreted ECG.
Secondary target parameters include the proportion of non-evaluable recordings in the overall study.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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AF
Five minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment
Five minutes puls wave recording
iPhone will be positioned on the index finger for five minutes to record a pulse wave
SR
Five minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment
Five minutes puls wave recording
iPhone will be positioned on the index finger for five minutes to record a pulse wave
Interventions
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Five minutes puls wave recording
iPhone will be positioned on the index finger for five minutes to record a pulse wave
Eligibility Criteria
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Inclusion Criteria
* patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
* informed consent
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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University Hospital Greifswald
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Jens Eckstein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universityhospital Basel
Locations
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University Hospital Greifswald
Greifswald, , Germany
University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Countries
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References
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Krivoshei L, Weber S, Burkard T, Maseli A, Brasier N, Kuhne M, Conen D, Huebner T, Seeck A, Eckstein J. Smart detection of atrial fibrillationdagger. Europace. 2017 May 1;19(5):753-757. doi: 10.1093/europace/euw125.
Brasier N, Raichle CJ, Dorr M, Becke A, Nohturfft V, Weber S, Bulacher F, Salomon L, Noah T, Birkemeyer R, Eckstein J. Detection of atrial fibrillation with a smartphone camera: first prospective, international, two-centre, clinical validation study (DETECT AF PRO). Europace. 2019 Jan 1;21(1):41-47. doi: 10.1093/europace/euy176.
Other Identifiers
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2016-01176
Identifier Type: -
Identifier Source: org_study_id