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A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle (RIVAFAG)

Primary Purpose

Atrial Fibrillation, Intracranial Hemorrhages

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Compare the risk of a vascular event
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with pericardial closure of the auricle

Patients without closure of the auricle

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 7, 2017
Last Updated
July 13, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03111654
Brief Title
A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle
Acronym
RIVAFAG
Official Title
A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 14, 2016 (Actual)
Primary Completion Date
October 19, 2017 (Actual)
Study Completion Date
October 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Intracranial Hemorrhages

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with pericardial closure of the auricle
Arm Type
Other
Arm Title
Patients without closure of the auricle
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Compare the risk of a vascular event
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle

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