NCT04354506

Brief Summary

Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

April 17, 2020

Last Update Submit

April 17, 2020

Conditions

Keywords

atrial fibrillationmobile technology

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrence

    Clinical episodes of atrial fibrillation, hospitalisation for atrial fibrillation

    1 year

Secondary Outcomes (2)

  • Stroke incidence

    1 year

  • Major bleeding incidence

    1 year

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients downloading specific AF mobile technology application

You may qualify if:

  • Paroxysmal or persistent atrial fibrillation

You may not qualify if:

  • unable to provide informed consent unable to have 1 year of follow-up for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dimitris Tsiachris, MD, PHD

    Institute of Longevity

    STUDY CHAIR

Central Study Contacts

Dimitris Tsiachris, MD, PHD

CONTACT

Athanasios Kordalis, MD, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Electrophysiology and Pacing Lab Director, Athens Heart Center

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

May 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2022

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share