Atrium; FibrillationDETECTAF-proNCT02949180
Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation
An observational study of Atrium; Fibrillation and Arrhythmia Atrial, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial summary
Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrium; Fibrillation, Arrhythmia Atrial
- What is being tested?
- Five minutes puls wave recording
- Type of treatment
- Medical device
- How many people
- 672 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at the University Hospital Basel
Who may be able to join
- Subjects of legal age,
- patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
- informed consent
Who cannot join
- Legally incompetent persons
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort.
Read the detailed description
Introduction This algorithm was validated earlier in a clinical trial with retrospective Data. The results were published accordingly.The algorithm is implemented in the commercial App Preventicus Heartbeats. DETECT AF is designed as prospective follow up trial.
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
- Atrium; Fibrillation, Arrhythmia Atrial
- Being tested
- Five minutes puls wave recording
- Keywords
- Atrial fibrillation, Rhythm monitoring, Cardiovascular App, m-health
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five minutes puls wave recordingDevice
iPhone will be positioned on the index finger for five minutes to record a pulse wave
| Study group | Role | What they receive |
|---|---|---|
| AF | Five minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment Receives: Device: Five minutes puls wave recording | |
| SR | Five minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment Receives: Device: Five minutes puls wave recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrium; FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Greifswald
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, MD, PhD, Principal investigator, Universityhospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949180
- Sponsor's protocol ID
- 2016-01176
- Other IDs
- 2016
- Acronym
- DETECTAF-pro
- Status last verified
- Dec 2017
- First submitted
- 27 Oct 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27371660Brasier 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.
PubMed 30085018
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation
- ClinicalTrials.gov ID
- NCT02949180
- Acronym / sponsor ID
- DETECTAF-pro / 2016-01176
- Conditions
- Atrium; Fibrillation, Arrhythmia Atrial
- Keywords
- Atrial fibrillation, Rhythm monitoring, Cardiovascular App, m-health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital Greifswald
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort.
Detailed description
Introduction This algorithm was validated earlier in a clinical trial with retrospective Data. The results were published accordingly.The algorithm is implemented in the commercial App Preventicus Heartbeats. DETECT AF is designed as prospective follow up trial.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF | – | Device: Five minutes puls wave recordingFive minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment |
| SR | – | Device: Five minutes puls wave recordingFive minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the University Hospital Basel
Key inclusion criteria (3 listed)
- Subjects of legal age,
- patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
- informed consent
Key exclusion criteria (1 listed)
- Legally incompetent persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Five minutes puls wave recordingiPhone will be positioned on the index finger for five minutes to record a pulse wave | Device | AF, SR |
Primary outcome
Correct detection of atrial fibrillation
Time frame: 5 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Results publication: PubMed 27371660Krivoshei 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.
- Derived from this study: PubMed 30085018Brasier 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.
- Individual participant dataSharing planned: No
Related trials for Atrium; Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, MD, PhD principal investigator
Universityhospital Basel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrium; Fibrillation and Arrhythmia Atrial, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct detection of atrial fibrillation (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949180, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.