Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older

NCT ID: NCT04375241

Last Updated: 2022-07-12

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

Total Enrollment

2168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-02

Study Completion Date

2021-04-30

Brief Summary

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Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen subjects opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all.

The main objectives are:

* To examine the feasibility of screening subjects of ≥65 years old for AAF.
* To validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.

Detailed Description

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Study design:

Prospective validation study.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Screening with Mobile ECG Device

Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Intervention Type OTHER

Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Interventions

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Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥65 years
* Is willing to give informed consent

Exclusion Criteria

* Known medical history with Atrial Fibrillation
* Not mental competent
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Diagram B.V.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Isala

Zwolle, Overijssel, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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9275

Identifier Type: -

Identifier Source: org_study_id

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