Atrial Fibrillation in Young Patients: a Prospective Mult... | NCT04776759

Studies
Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry

NCT04776759

Sponsor

University Hospital, Caen

Status

Recruiting

Last Update Posted

Mar 2, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Atrial Fibrillation
Lone Atrial Fibrillation

Interventions

Not provided

Countries

France

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 1, 2031Estimated

Completion Date

Jan 1, 2031Estimated

First Submitted Date

Sep 3, 2020

First Submission Date that Met QC Criteria

Feb 25, 2021

First Posted Date

Mar 2, 2021Actual

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

Feb 25, 2021

Last Update Posted Date

Mar 2, 2021Actual

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 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.

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.

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

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pierre Ollitrault, MD, MSc	Contact	0231063106		ollitrault-p@chu-caen.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hospital	Recruiting	Caen	Normandy	14000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

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