Left Atrial Appendage Closure Registry of Henri Mondor Hospital
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SA brief descriptive name used to refer to the intervention(s) studied.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Other SA brief descriptive name used to refer to the intervention(s) studied
Details that can be made public about the intervention
Primary outcome measures
- Frequency of thrombo-embolic events [Time frame: 60months of follow-up after the procedure]
Secondary outcome measures (12)
- Efficacy of the procedure [Time frame: One hour after the end of the procedure]
- Occlusion of the left atrial appendage [Time frame: 3 months]
- residual peri-device leak [Time frame: 3 months]
- Percentage of ischemic stroke [Time frame: 1 and 5 years after the procedure]
- Percentage of transient ischemic attack (TIA) [Time frame: 1 and 5 years after the procedure]
- Percentage of systemic embolism [Time frame: 1 and 5 years after the procedure]
- Cardiovascular or unexplained death [Time frame: 1 and 5 years after the procedure]
- All-cause mortality [Time frame: 1 and 5 years after the procedure]
- Comparison of the rate of thromboembolic events to expected values [Time frame: 1 and 5 years after the procedure]
- Rate of complications related or potentially related to the device or the implantation procedure [Time frame: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)]
- Percentage of pericardial effusion [Time frame: Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)]
- Percentage of pericardial effusion [Time frame: 3 months]
Eligibility 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
- Refusal of the patient to participate in this study
- Minor patient
- Patient not affiliated to the French social security system
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR — Créteil
Identifiers
NCT: NCT05565209 · APHP220614