NCT04776759

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress53%
Jan 2021Jan 2031

First Submitted

Initial submission to the registry

September 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

March 2, 2021

Status Verified

August 1, 2020

Enrollment Period

10 years

First QC Date

September 3, 2020

Last Update Submit

February 25, 2021

Conditions

Atrial FibrillationLone Atrial Fibrillation

Keywords

Atrial FibrillationLone Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Composite of mortality, thromboembolic event and heart failure

    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.

    Incidence of symptomatic atrial fibrillation at 10-year after initial diagnosis of atrial fibrillation.

    at 10-year

Eligibility Criteria

AgeUp to 35 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, Normandy, 14000, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre Ollitrault, MD, MSc

CONTACT

0231063106ollitrault-p@chu-caen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

March 2, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Last Updated

March 2, 2021

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)