Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation

Completed

• Conditions: Atrium; Fibrillation; Arrhythmia Atrial
• Interventions: Device: Five minutes puls wave recording

• Registration Number: NCT02949180
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 672

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SR	Five minutes puls wave recording	Five minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment
AF	Five minutes puls wave recording	Five minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment

Primary Outcome Measures

Name	Time	Method
Correct detection of atrial fibrillation	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

Trial Locations

Locations (2)

University Hospital Greifswald; 🇩🇪 Greifswald, Germany

University Hospital Basel; 🇨🇭 Basel, BS, Switzerland