Clinical trial NCT02949180: Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation
Official title: Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrium; Fibrillation
Arrhythmia Atrial
Keywords: Atrial fibrillation
Rhythm monitoring
Cardiovascular App
m-health
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Hospital Greifswald
First posted: 2016-10-31
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at the University Hospital Basel

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects of legal age,
* patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
* informed consent

Exclusion Criteria:

* Legally incompetent persons

Primary outcomes:
measure: Correct detection of atrial fibrillation
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Hospital Greifswald
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
affiliation: Universityhospital Basel
name: Jens Eckstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.