Atrial FibrillationFAIRNCT06620575
Evaluation of Predictive Factors for Recurrence of Persistent Atrial Fibrillation After Ablation
An observational study of Atrial Fibrillation, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This is a single-center, retrospective, observational study based on data extracted from the medical records of patients who underwent a procedure for persistent atrial fibrillation ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial fibrillation ablation
- Type of treatment
- Surgery or procedure
- How many people
- 542 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014
Who may be able to join
- Patient aged 18 years or older, who has been informed about the research
- Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014
- Patient for whom data regarding the ablation procedure are available
Who cannot join
- Patient under legal protection, guardianship, or conservatorship
- Patient who has expressed opposition to the use of their medical data (by completing and returning the opt-out form provided)
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center, retrospective, observational study based on data extracted from the medical records of patients who underwent a procedure for persistent atrial fibrillation ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial fibrillation ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationProcedure or surgery
Persistent atrial fibrillation ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of persistent atrial fibrillation
The main objective of the study is to assess to what extent patient characteristics and conditions during the atrial fibrillation ablation procedure can identify predictive factors for recurrence.
Recurrence (Yes/No) is the outcome variable to be explained.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start29 Mar 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Retrospective
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620575
- Sponsor's protocol ID
- 2020-12-033
- Acronym
- FAIR
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Predictive Factors for Recurrence of Persistent Atrial Fibrillation After Ablation
- ClinicalTrials.gov ID
- NCT06620575
- Acronym / sponsor ID
- FAIR / 2020-12-033
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Oct 2024 (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.
This is a single-center, retrospective, observational study based on data extracted from the medical records of patients who underwent a procedure for persistent atrial fibrillation ablation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014
Key inclusion criteria (3 listed)
- Patient aged 18 years or older, who has been informed about the research
- Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014
- Patient for whom data regarding the ablation procedure are available
Key exclusion criteria (2 listed)
- Patient under legal protection, guardianship, or conservatorship
- Patient who has expressed opposition to the use of their medical data (by completing and returning the opt-out form provided)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial fibrillation ablationPersistent atrial fibrillation ablation | Procedure or surgery | – |
Primary outcome
Recurrence of persistent atrial fibrillation
Time frame: Month 12
The main objective of the study is to assess to what extent patient characteristics and conditions during the atrial fibrillation ablation procedure can identify predictive factors for recurrence. Recurrence (Yes/No) is the outcome variable to be explained.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of persistent atrial fibrillation (time frame: Month 12). 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 1 Oct 2024.