Left Atrial Appendage Closure Registry of Henri Mondor Hospital (FLAAC3)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Other: SA brief descriptive name used to refer to the intervention(s) studied

Study type: Observational

Funder types: Other

Identifiers

NCT05565209

APHP220614

Details and patient eligibility

About

Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.

Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.

Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient for whom an indication has been made for implantation of a device for the closure of the left atrial appendage without restriction of indication and regardless of the outcome of the procedure (implantation success or not)

Exclusion criteria

• Refusal of the patient to participate in this study
• Minor patient
• Patient not affiliated to the French social security system