NCT03111654: RIVAFAG

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

Completed NA Last updated 19 November 2025

What this trial tests

NA trial testing Compare the risk of a vascular event in Atrial Fibrillation in 58 participants. Completed in 19 October 2017.

Timeline

14 July 2016

Primary endpoint
19 October 2017

19 October 2017

Quick facts

Lead sponsor	Centre Hospitalier Universitaire, Amiens
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	screening
Enrollment	58
Start date	14 July 2016
Primary completion	19 October 2017
Estimated completion	19 October 2017
Sites	1 location across France

Drugs / interventions tested

• Compare the risk of a vascular event

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Intracranial Hemorrhages — all drugs for Intracranial Hemorrhages →

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, any sex, with Atrial Fibrillation or Intracranial Hemorrhages. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.