Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry (YOUNG-AF)

February 25, 2021 updated by: University Hospital, Caen
Atrial fibrillation is a rare cardiac arrhythmia in young (i.e. <= 35-year-old) patients. Etiological factors, current management and mid- to long-term outcomes remain unknown.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Atrial Fibrillation in YOUNG patients (YOUNG-AF) is a prospective, observational, multicentric registry, including every consecutive patients aged < 35-year-old with a diagnosis of atrial fibrillation. The registry will assess demographical, physical activity, toxicologic and genetic factors, as well as current management regarding anticoagulation, anti-arrhythmic drugs and catheter ablation. As an observational registry, patient will be managed with the guidelines-directed standard-of-care.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, 14000
        • Recruiting
        • Caen University Hospital
        • Contact:

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

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Young patients (i.e. < or = to 35-year-old) at the time of first atrial fibrillation episode.

Description

Inclusion Criteria:

  • First episode of atrial fibrillation
  • Less than 35-year-old
  • Diagnostic by 12-lead ECG or continuous monitoring (minimal duration 30 seconds)
  • French Social Security number

Exclusion Criteria:

  • Transvenous cardiac implantable electronic device (insertable cardiac monitors are not an exclusion criteria)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of mortality, thromboembolic event and heart failure
Time Frame: at 10-year
Incidence of all-cause mortality, symptomatic thromboembolic event and congestive heart failure at 10-year after initial diagnosis of atrial fibrillation.
at 10-year
Recurrent symptomatic atrial fibrillation.
Time Frame: at 10-year
Incidence of symptomatic atrial fibrillation at 10-year after initial diagnosis of atrial fibrillation.
at 10-year

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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 (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2031

Study Completion (Anticipated)

January 1, 2031

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rythmo20200901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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