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

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 Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: SA brief descriptive name used to refer to the intervention(s) studied

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Emmanuel Teiger, MD, PhD; Phone Number: 00 33 1 49 81 22 51; Email: emmanuel.teiger@aphp.fr
• Study Contact Backup: Name: Philippe Le Corvoisier, MD, PhD; Phone Number: +33149813790; Email: philippe.lecorvoisier@aphp.fr

Study Locations

• France
  • Créteil, France, 94010
    • Recruiting
    • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A description of the population from which the groups or cohorts will be selected

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60months of follow-up after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 months
Percentage of ischemic stroke	Percentage of patients with at least one ischemic stroke during the study	1 and 5 years after the procedure
Percentage of transient ischemic attack (TIA)	Percentage of patients presenting at least one systemic embolism during the study	1 and 5 years after the procedure
Percentage of systemic embolism	Percentage of patients presenting at least one systemic embolism during the study	1 and 5 years after the procedure
Cardiovascular or unexplained death	Percentage of patients who had a cardiovascular or unexplained death during the study	1 and 5 years after the procedure
All-cause mortality	percentage of all cause deaths	1 and 5 years after the procedure
Comparison of the rate of thromboembolic events to expected values	the observed rate of thromboembolic event will be compared to the expected value, according the individual patients CHA2DS2-VASc scores	1 and 5 years after the procedure
Rate of complications related or potentially related to the device or the implantation procedure	: Rate of complications related or potentially related to the device or the implantation procedure	periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of pericardial effusion	Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound	Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of pericardial effusion	Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound	3 months
Percentage of migration of the device	Percentage of patients who presented a migration of the device, objectified by echocardiography and / or CT scan	periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
Percentage of migration of the device	: Percentage of patients who presented a migration of the device, objectified by the echocardiography and / or CT scan	3 months; 1 year; 5 years
Percentage of device thrombosis	Percentage of patients who presented a thrombosis on the device, objectified by transesophageal echography and / or CT scan	3 months; 1 year; 5 year
Bleeding (all cause)	Percentage of patients who presented a bleeding	1 year; 5 year
Bleedings not-related to the procedure or the device	Percentage of patients who presented a bleeding not-related to the procedure or the device	1 year; 5 year
Criteria for Evaluating Associated Antithrombotic Treatments	The antithrombotic treatments will be collected at different follow-up times. The type and duration of anti-thrombotic treatments will be documented using the combined criteria: Percentage of patients on injectable or oral anticoagulants and antiplatelet agents at different follow-up times; Percentage of patients on injectable or oral anticoagulants at different follow-up times; The percentage of patients on platelet antiaggregants in single or dual therapy at different follow-up times	: Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure
Description of the population	Demographic and clinical characteristics of the patients will be collected and described, such as: age, sex, medical and surgical history, cardiovascular pharmacological treatments, comorbidities, indication of left atrial closure, HAS-BLED and CHA2DS2-VASc scores, anatomical features of the left atrial appendage at inclusion.	At inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2022
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): September 14, 2026

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Atrial fibrillation, Left atrial appendage closure, stroke, anticoagulation, bleeding
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Hemorrhage
• Other Study ID Numbers: APHP220614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No