Atrial FibrillationRIVAFAGNCT03111654
A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle
A study testing Compare the risk of a vascular event in people with Atrial Fibrillation and Intracranial Hemorrhages, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Intracranial Hemorrhages
- What is being tested?
- Compare the risk of a vascular event
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jul 2016to 19 Oct 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18 years or older
- Affiliation to a social security scheme
- Non-valvular, paroxysmal, persistent or permanent atrial fibrillation
- CHA2DS2-VASc greater than or equal to 2
- History of intracranial haemorrhage: Intra-parenchymal hematoma, subacute or chronic subcutaneous hematoma And
- Patients having benefited from the percutaneous closure of the auricle at the University Hospital of Amiens
- Either patient admitted to the CHU of Amiens in neurology, neurosurgery or geriatrics for intracranial haemorrhage, who received standard medical treatment for the comparison group.
Who cannot join
- CHADS2VASC2 less than 2
- Extradural hematoma
- Arachnoidal haemorrhage by rupture of aneurysm
- Haemorrhagic transformation of ischemic stroke
- Other indication of anticoagulation than FA
- Modified Rankin scale greater than 4 following intracranial hemorrhage.
- Early death, in the month following the onset of intracranial hemorrhage.
Trial locations and contacts
1 site in 1 country.
About this study
Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability. Preventing the thromboembolic risk associated with FMD is therefore a public health issue. The reference treatment is oral anticoagulation but this treatment is contraindicated in patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle is a recent technique which makes it possible to exclude this appendix from the left atrium where the majority of thrombi are formed in the framework of the AF. Comparative studies have shown the effectiveness of this technique, appearing to be similar to that of anticoagulation. However, in view of the per-procedural risk, the indication of closure was retained by the health authorities only in the event of a contraindication to oral anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients with a history of intracranial hemorrhage are therefore candidates for this technique, but there are few studies where these patients were included. The risk-benefit must be demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming functional and cognitive.
- Conditions
- Atrial Fibrillation, Intracranial Hemorrhages
- Being tested
- Compare the risk of a vascular event
- Medical subject headings
- Atrial Fibrillation, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare the risk of a vascular eventDiagnostic test
Collected in a post-stroke follow-up consultation, patient clinical outcome data, functional and cognitive disability, standardized, using validated scales.
Analysis of selected therapeutic options for the prevention of AF ischemic events.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pericardial closure of the auricle | Other | Not described Receives: Diagnostic Test: Compare the risk of a vascular event |
| Patients without closure of the auricle | Other | Not described Receives: Diagnostic Test: Compare the risk of a vascular event |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the risk of vascular event (ischemic stroke, haemorrhagic stroke, systemic embolism or cardiovascular or indeterminate death) in patients treated at the Amiens University Hospital with a history of AF and intracranial haemorrhage
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start14 Jul 2016
- Primary completion19 Oct 2017
- Study completion19 Oct 2017
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 Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111654
- Sponsor's protocol ID
- PI2016_843_0005
- Acronym
- RIVAFAG
- Status last verified
- Nov 2025
- First submitted
- 7 Apr 2017
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle
- ClinicalTrials.gov ID
- NCT03111654
- Acronym / sponsor ID
- RIVAFAG / PI2016_843_0005
- Conditions
- Atrial Fibrillation, Intracranial Hemorrhages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2017 (actual)
- First posted
- 13 Apr 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.
Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability. Preventing the thromboembolic risk associated with FMD is therefore a public health issue. The reference treatment is oral anticoagulation but this treatment is contraindicated in patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle is a recent technique which makes it possible to exclude this appendix from the left atrium where the majority of thrombi are formed in the framework of the AF. Comparative studies have shown the effectiveness of this technique, appearing to be similar to that of anticoagulation. However, in view of the per-procedural risk, the indication of closure was retained by the health authorities only in the event of a contraindication to oral anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients with a history of intracranial hemorrhage are therefore candidates for this technique, but there are few studies where these patients were included. The risk-benefit must be demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming functional and cognitive.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pericardial closure of the auricle | Other | Diagnostic Test: Compare the risk of a vascular event |
| Patients without closure of the auricle | Other | Diagnostic Test: Compare the risk of a vascular event |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 years or older
- Affiliation to a social security scheme
- Non-valvular, paroxysmal, persistent or permanent atrial fibrillation
- CHA2DS2-VASc greater than or equal to 2
- History of intracranial haemorrhage: Intra-parenchymal hematoma, subacute or chronic subcutaneous hematoma And
Key exclusion criteria (7 listed)
- CHADS2VASC2 less than 2
- Extradural hematoma
- Arachnoidal haemorrhage by rupture of aneurysm
- Haemorrhagic transformation of ischemic stroke
- Other indication of anticoagulation than FA
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 |
|---|---|---|
| Compare the risk of a vascular eventCollected in a post-stroke follow-up consultation, patient clinical outcome data, functional and cognitive disability, standardized, using validated scales. Analysis of selected therapeutic options for the prevention of AF ischemic events. | Diagnostic test | Patients with pericardial closure of the auricle, Patients without closure of the auricle |
Primary outcome
Compare the risk of vascular event (ischemic stroke, haemorrhagic stroke, systemic embolism or cardiovascular or indeterminate death) in patients treated at the Amiens University Hospital with a history of AF and intracranial haemorrhage
Time frame: 1 hours
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 19 Nov 2025.
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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. 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?
A study testing Compare the risk of a vascular event in people with Atrial Fibrillation and Intracranial Hemorrhages, run by Centre Hospitalier Universitaire, Amiens 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 7 inclusion and 7 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 19 Nov 2025. 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?
Compare the risk of vascular event (ischemic stroke, haemorrhagic stroke, systemic embolism or cardiovascular or indeterminate death) in patients treated at the Amiens University Hospital with a history of AF and intracranial haemorrhage (time frame: 1 hours). 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 19 Nov 2025.