Clinical trial NCT05565209: Left Atrial Appendage Closure Registry of Henri Mondor Hospital
Official title: Left Atrial Appendage Closure Registry of Henri Mondor Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation, Left atrial appendage closure, stroke, anticoagulation, bleeding
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A description of the population from which the groups or cohorts will be selected

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.


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

Primary outcomes:
measure: Frequency of thrombo-embolic events
timeFrame: 60months of follow-up after the procedure
Secondary outcomes:
measure: Efficacy of the procedure
timeFrame: One hour after the end of the procedure
measure: Occlusion of the left atrial appendage
timeFrame: 3 months
measure: residual peri-device leak
timeFrame: 3 months
measure: Percentage of ischemic stroke
timeFrame: 1 and 5 years after the procedure
measure: Percentage of transient ischemic attack (TIA)
timeFrame: 1 and 5 years after the procedure
measure: Percentage of systemic embolism
timeFrame: 1 and 5 years after the procedure
measure: Cardiovascular or unexplained death
timeFrame: 1 and 5 years after the procedure
measure: All-cause mortality
timeFrame: 1 and 5 years after the procedure
measure: Comparison of the rate of thromboembolic events to expected values
timeFrame: 1 and 5 years after the procedure
measure: Rate of complications related or potentially related to the device or the implantation procedure
timeFrame: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
measure: Percentage of pericardial effusion
timeFrame: Periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
measure: Percentage of pericardial effusion
timeFrame: 3 months
measure: Percentage of migration of the device
timeFrame: periprocedural period (defined as the time from the day of the procedure to day 7 or discharge, whichever comes last)
measure: Percentage of migration of the device
timeFrame: 3 months; 1 year; 5 years
measure: Percentage of device thrombosis
timeFrame: 3 months; 1 year; 5 year
measure: Bleeding (all cause)
timeFrame: 1 year; 5 year
measure: Bleedings not-related to the procedure or the device
timeFrame: 1 year; 5 year
measure: Criteria for Evaluating Associated Antithrombotic Treatments
timeFrame: : Discharge, 3, 6, 12 months after the procedure, 1 and 5 years after the procedure
measure: Description of the population
timeFrame: At inclusion
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Study officials:
References: