Detection of Asymptomatic Atrial Fibrillation in Persons... | NCT04375241

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

NCT04375241

Sponsor

Diagram B.V.

Status

Completed

Last Update Posted

Jul 12, 2022Actual

Enrollment

2,168Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

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

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2018Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Apr 30, 2021Actual

First Submitted Date

May 1, 2020

First Submission Date that Met QC Criteria

May 1, 2020

First Posted Date

May 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2022

Last Update Posted Date

Jul 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Study design:

Prospective validation study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Screening with Mobile ECG Device		Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device	Other: Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device	Other	Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity of the mobile ECG device		At screening
Specificity of the mobile ECG device		At screening

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥65 years
Is willing to give informed consent

Exclusion Criteria:

Known medical history with Atrial Fibrillation
Not mental competent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

The participants of this study will be subjects who visit their general practicioner or cardiologist or who visit the DETECT AF team at an event.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isala		Zwolle	Overijssel	8025AB	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

We have not yet decided to share the individual participant data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided