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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

NCT03111654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Compare the risk of a vascular event

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-14
Primary Completion
2017-10-19
Completion
2017-10-19

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111654 on ClinicalTrials.gov