Fibricheck Detection cApabilities for Atrial Fibrillation

NCT ID: NCT06282380

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2024-06-26

Brief Summary

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Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FibriCheck Mobile Application measurements

Participants will perform one measurement using the FibriCheck Mobile Application and the result will be compared with the ground truth.

Group Type OTHER

FibriCheck Mobile Application

Intervention Type DEVICE

PPG measurement with reference diagnosis

Interventions

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FibriCheck Mobile Application

PPG measurement with reference diagnosis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* At least 22 years old;
* Capable of independently performing FibriCheck recordings (researcher-observed);
* Cardiology patients, hospitalized/in-clinic or consulting the cardiac outpatient clinic, with or without a diagnosis of atrial fibrillation.

Exclusion Criteria

* Individuals with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can influence the natural heart rhythm;
* Individuals enrolled in another clinical trial;
* Individuals with physical or medical characteristics that prevent them from successfully taking a measurement e.g. extreme callus (i.e., rough or thickened area of skin fingertip), tremor, cognitive impairment, Parkinson's disease;
* Pregnant and/or nursing women.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qompium NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwestern Medicin

Chicago, Illinois, United States

Site Status

New York Presebyterian Queens

New York, New York, United States

Site Status

OU Medicine College

Oklahoma City, Oklahoma, United States

Site Status

University Hospital Antwerp

Antwerp, , Belgium

Site Status

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

Countries

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United States Belgium

Other Identifiers

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FDA-AF study

Identifier Type: -

Identifier Source: org_study_id

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