Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation

Atrium; Fibrillation Clinical Trial

— DETECTAF-pro  

Official title:

Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949180
• Other study ID #: 2016-01176
• Status: Completed
• Phase: N/A
• First received: October 27, 2016
• Last updated: December 12, 2017
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia Atrial
• Atrial Fibrillation
• Atrium; Fibrillation

Intervention

Device:
• Five minutes puls wave recording
iPhone will be positioned on the index finger for five minutes to record a pulse wave

Locations

Country	Name	City	State
Germany	University Hospital Greifswald	Greifswald
Switzerland	University Hospital Basel	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Hospital Greifswald

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Krivoshei L, Weber S, Burkard T, Maseli A, Brasier N, Kühne M, Conen D, Huebner T, Seeck A, Eckstein J. Smart detection of atrial fibrillation†. Europace. 2017 May 1;19(5):753-757. doi: 10.1093/europace/euw125. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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