Atrial FibrillationRELEXAONCT03279406
REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion
An observational study of Atrial Fibrillation, run by University Hospital, Tours.
Trial summary
The objective of this observational non-randomized multicenter study is to compile real-world clinical characteristics and outcomes data for patients treated with LAA (left atrial appendage) closure systems in a daily clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Percutaneous Left Atrial Appendage Occlusion
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2012to 1 Sep 2018
- How long will I take part?
- 60 Months
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated with percutaneous Left Atrial Appendage Occlusion among those referred to one of the French centers involved in this database
Who may be able to join
- Patients who are eligible for a LAA occlusion device and treated with a commercially available device according to international and local guidelines and per physician discretion.
Who cannot join
- None
About this study
Official title: REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion for Patients With Atrial Fibrillation in France
The objective of this observational non-randomized multicenter study is to compile real-world clinical characteristics and outcomes data for patients treated with LAA (left atrial appendage) closure systems in a daily clinical setting.
- Conditions
- Atrial Fibrillation
- Being tested
- Percutaneous Left Atrial Appendage Occlusion
- Keywords
- Atrial fibrillation, Stroke, Thrombus, Left atrial appendage, Bleeding
- Medical subject headings
- Atrial Fibrillation, Stroke, Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Left Atrial Appendage OcclusionDevice
Percutaneous left atrial appendage occlusion in routine care for patients with atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Death, Ischemic stroke, Transient ischemic attack, Major hemorrhage, Thrombus on device
Measured: From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Feb 2012
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent Fauchier, University Hospital, Tours
- Investigators
- Laurent Fauchier, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279406
- Sponsor's protocol ID
- Cardio Tours RELEXAO
- Acronym
- RELEXAO
- Status last verified
- May 2024
- First submitted
- 6 Sep 2017
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.
PubMed 29622159
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion for Patients With Atrial Fibrillation in France
- ClinicalTrials.gov ID
- NCT03279406
- Acronym / sponsor ID
- RELEXAO / Cardio Tours RELEXAO
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Stroke, Thrombus, Left atrial appendage, Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 12 Sep 2017 (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.
The objective of this observational non-randomized multicenter study is to compile real-world clinical characteristics and outcomes data for patients treated with LAA (left atrial appendage) closure systems in a daily clinical setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with percutaneous Left Atrial Appendage Occlusion among those referred to one of the French centers involved in this database
Key inclusion criteria (1 listed)
- Patients who are eligible for a LAA occlusion device and treated with a commercially available device according to international and local guidelines and per physician discretion.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Percutaneous Left Atrial Appendage OcclusionPercutaneous left atrial appendage occlusion in routine care for patients with atrial fibrillation | Device | – |
Primary outcome
Major adverse cardiovascular events
Time frame: From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months
Death, Ischemic stroke, Transient ischemic attack, Major hemorrhage, Thrombus on device
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 14 May 2024.
- Derived from this study: PubMed 29622159Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.
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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.
Laurent Fauchier, MD, PhD principal investigator
Centre Hospitalier Universitaire de Tours
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital, Tours.
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 1 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: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Major adverse cardiovascular events (time frame: From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279406, which also lists 1 linked publication.
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 14 May 2024.