Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation (DETECTAF-pro)

December 12, 2017 updated by: University Hospital, Basel, Switzerland
Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App in a prospective cohort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

672

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • University Hospital Greifswald
  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients at the University Hospital Basel

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AF
Five minutes puls wave recording will be performed in patients in atrial fibrillation at time of recruitment
Device: Five minutes puls wave recording
iPhone will be positioned on the index finger for five minutes to record a pulse wave
SR
Five minutes puls wave recording will be performed in patients in sinus rhythm at time of recruitment
Device: Five minutes puls wave recording
iPhone will be positioned on the index finger for five minutes to record a pulse wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital Greifswald

Investigators

  • Principal Investigator: Jens Eckstein, MD, PhD, Universityhospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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