Atrial FibrillationYOUNG-AFNCT04776759
Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry
An observational study of Atrial Fibrillation and Lone Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 35 years
- Conditions the study is for
- Atrial Fibrillation, Lone Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Jan 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- All sexes
- Child, Adult
Study population: Young patients (i.e. < or = to 35-year-old) at the time of first atrial fibrillation episode.
Who may be able to join
- 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
Who cannot join
- Transvenous cardiac implantable electronic device (insertable cardiac monitors are not an exclusion criteria)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, Normandy, 14000
Pierre Ollitrault, MD, MSc, 0231063106, ollitrault-p@chu-caen.fr
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Lone Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Lone Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 10-year
Recurrent symptomatic atrial fibrillation.
Incidence of symptomatic atrial fibrillation at 10-year after initial diagnosis of atrial fibrillation.
Measured: at 10-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776759
- Sponsor's protocol ID
- Rythmo20200901
- Acronym
- YOUNG-AF
- Status last verified
- Aug 2020
- First submitted
- 3 Sep 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry
- ClinicalTrials.gov ID
- NCT04776759
- Acronym / sponsor ID
- YOUNG-AF / Rythmo20200901
- Conditions
- Atrial Fibrillation, Lone Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Lone Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Young patients (i.e. < or = to 35-year-old) at the time of first atrial fibrillation episode.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Transvenous cardiac implantable electronic device (insertable cardiac monitors are not an exclusion criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Recurrent symptomatic atrial fibrillation.
Time frame: at 10-year
Incidence of symptomatic atrial fibrillation at 10-year after initial diagnosis of atrial fibrillation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Lone Atrial Fibrillation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Ollitrault, MD, MSc (0231063106, ollitrault-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of mortality, thromboembolic event and heart failure (time frame: at 10-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.