FLAAC3: Left Atrial Appendage Closure Registry of Henri Mondor Hospital
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Frequency of thrombo-embolic events [60months of follow-up after the procedure]
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.
Secondary Outcome Measures
- Efficacy of the procedure [One hour after the end 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
- Occlusion of the left atrial appendage [3 months]
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
- residual peri-device leak [3 months]
The percentage a patients with 3 months residual peri-device leak will be determined at transesophageal echography and / or CT scan
- Percentage of ischemic stroke [1 and 5 years after the procedure]
Percentage of patients with at least one ischemic stroke during the study
- Percentage of transient ischemic attack (TIA) [1 and 5 years after the procedure]
Percentage of patients presenting at least one systemic embolism during the study
- Percentage of systemic embolism [1 and 5 years after the procedure]
Percentage of patients presenting at least one systemic embolism during the study
- Cardiovascular or unexplained death [1 and 5 years after the procedure]
Percentage of patients who had a cardiovascular or unexplained death during the study
- All-cause mortality [1 and 5 years after the procedure]
percentage of all cause deaths
- Comparison of the rate of thromboembolic events to expected values [1 and 5 years after the procedure]
the observed rate of thromboembolic event will be compared to the expected value, according the individual patients CHA2DS2-VASc scores
- 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)]
: Rate of complications related or potentially related to the device or the implantation procedure
- Percentage of pericardial effusion [Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)]
Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound
- Percentage of pericardial effusion [3 months]
Percentage of patients who presented a pericardial effusion objectified by trans-thoracic ultrasound
- Percentage of migration of the device [periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)]
Percentage of patients who presented a migration of the device, objectified by echocardiography and / or CT scan
- Percentage of migration of the device [3 months; 1 year; 5 years]
: Percentage of patients who presented a migration of the device, objectified by the echocardiography and / or CT scan
- Percentage of device thrombosis [3 months; 1 year; 5 year]
Percentage of patients who presented a thrombosis on the device, objectified by transesophageal echography and / or CT scan
- Bleeding (all cause) [1 year; 5 year]
Percentage of patients who presented a bleeding
- Bleedings not-related to the procedure or the device [1 year; 5 year]
Percentage of patients who presented a bleeding not-related to the procedure or the device
- Criteria for Evaluating Associated Antithrombotic Treatments [: Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure]
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
- Description of the population [At inclusion]
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.
Eligibility Criteria
Criteria
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:
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Refusal of the patient to participate in this study
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Minor patient
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Patient not affiliated to the French social security system
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR | Créteil | France | 94010 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP220614