Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation
DETECTAF-pro
1 other identifier
observational
672
2 countries
2
Brief Summary
Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedDecember 13, 2017
December 1, 2017
1.1 years
October 27, 2016
December 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correct detection of atrial fibrillation
iPhone will be positioned on the index finger for five minutes to record a pulse wave; Algorithm should correctly differentiate between AF patients and SR patients
5 minutes
Study Arms (2)
AF
Five minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment
SR
Five minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment
Interventions
iPhone will be positioned on the index finger for five minutes to record a pulse wave
Eligibility Criteria
Patients at the University Hospital Basel
You may qualify if:
- Subjects of legal age,
- patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
- informed consent
You may not qualify if:
- Legally incompetent persons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Greifswald
Greifswald, 17475, Germany
University Hospital Basel
Basel, Canton of Basel-City, 4031, Switzerland
Related Publications (2)
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.
PMID: 27371660RESULTBrasier 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.
PMID: 30085018DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Eckstein, MD, PhD
Universityhospital Basel
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 31, 2016
Study Start
October 1, 2016
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
December 13, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share