Left Atrial Appendage Closure Registry of Henri Mondor Hospital

Atrial Fibrillation Clinical Trial

— FLAAC3  

Official title:

Left Atrial Appendage Closure Registry of Henri Mondor Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05565209
• Other study ID #: APHP220614
• Status: Not yet recruiting
• Start date: September 26, 2022
• Est. completion date: September 14, 2024

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Emmanuel Teiger, MD, PhD
• Phone: 00 33 1 49 81 22 51
• Email: emmanuel.teiger[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 14, 2024
• Est. primary completion date: September 14, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• SA brief descriptive name used to refer to the intervention(s) studied
Details that can be made public about the intervention

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage of ischemic stroke	Percentage of patients with at least one ischemic stroke during the study	1 and 5 years after the procedure
Secondary	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
Secondary	Percentage of systemic embolism	Percentage of patients presenting at least one systemic embolism during the study	1 and 5 years after the procedure
Secondary	Cardiovascular or unexplained death	Percentage of patients who had a cardiovascular or unexplained death during the study	1 and 5 years after the procedure
Secondary	All-cause mortality	percentage of all cause deaths	1 and 5 years after the procedure
Secondary	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
Secondary	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)
Secondary	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)
Secondary	Percentage of pericardial effusion	Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound	3 months
Secondary	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)
Secondary	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
Secondary	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
Secondary	Bleeding (all cause)	Percentage of patients who presented a bleeding	1 year; 5 year
Secondary	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
Secondary	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
Secondary	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