Left Atrial Appendage Closure Registry of Henri Mondor Hospital

Assistance Publique - Hôpitaux de Paris250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency of thrombo-embolic events

The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes and systemic embolisms after left atrial appendage closure. This frequency will be expressed as the percentage of patients who presented at least one of these events. Only the first event occurring in each patient will be taken into account, in the case where the same patient would present several events.

Time frame: 60months of follow-up after the procedure

Secondary Outcomes

Efficacy of the procedure

: At the end of the procedure, the efficiency of the procedure will be described by the percentage of success of the procedure. The successful procedure is defined by a successful implantation of the device in the left atrial appendage without presaging its occlusive character. One hour after the end of the procedure

Time frame: One hour after the end of the procedure

Occlusion of the left atrial appendage

The percentage of left atrial appendage occlusion is defined as the percentage of patients where left atrial appendage is efficiently closed at by transesophageal echography and / or CT scan Time Frame: 3 months

Time frame: 3 months

residual peri-device leak

The percentage a patients with 3 months residual peri-device leak will be determined at transesophageal echography and / or CT scan

Time frame: 3 months

Percentage of ischemic stroke

Percentage of patients with at least one ischemic stroke during the study