Post-approval Study of Percutaneous Left Atrial Appendage Closure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- French Cardiology Society
- Enrollment
- 1051
- Locations
- 1
- Primary Endpoint
- Frequency of events at one year
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is a new 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 can 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. In 2016, two devices developed for transcutaneous closure of the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude Medical and its evolution AMPLATZER AMULET) were included in the list of products reimbursable in France. The French national authorities have requested the realization of a register whose objectives will be to evaluate:
- The efficiency and safety of implanting devices in France
- The type and duration of antithrombotic treatment prescribed after left atrial appendage closure
Investigators
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).ot).
Exclusion Criteria
- •Refusal of the patient to participate in this study and therefore the use of his data
- •Minor patient
Outcomes
Primary Outcomes
Frequency of events at one year
Time Frame: 1 year
The primary efficacy endpoint is the frequency of a combined endpoint including ischemic strokes, systemic embolism, unexplained deaths, and cardiovascular death one year 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 concerned will be taken into account, in the case where the same patient would present several events.
Secondary Outcomes
- Percentage of transient ischemic attack (TIA) at 1 year of follow up(1 year of follow up)
- Percentage of pericardial effusion after 7 days of follow up(7 days of follow up or discharge (if later then D7))
- Percentage of migration of the device after 7 days of follow up(7 days of follow up or discharge (if later then D7))
- Percentage of device migration at 3 months of follow up(3 months of follow up)
- Percentage of ischemic stroke at 1 year of follow up(1 year of follow up)
- Percentage of systemic embolism at 1 year of follow up(1 year of follow up)
- Mortality at 1 year of follow up(1 year of follow up)
- Frequency of cerebral or systemic ischemic events at 1 year of follow up(1 year of follow up)
- Percentage of device thrombosis at 3 months of follow up(3 months of follow up)
- Clinical evolution of the patient at 1 year(1 year of follow up)
- Efficacy at the end of the procedure(One hour after the end of the procedure)
- Percentage of occlusion of the left atrial appendage objectified by transesophageal echography at 3 months of follow up(3 months of follow up)
- Percentage of residual leakage revealed by transesophageal echocardiography at 3 months of follow up(3 months of follow up)
- Rate of complications related or potentially related to the device or the implantation procedure after 7 days of follow up(7 days of follow up or discharge (if later then D7))
- Evaluation of implantation indications(At inclusion)
- Percentage of cardiovascular or unexplained death at 1 year of follow up(1 year of follow up)
- Rate of complications related or potentially related to the device or procedure after 1 year of follow up(1 year of follow up)
- Device thrombosis or device migrations by trans-thoracic ultrasound after 1 year of follow up(1 year of follow up)
- Criteria for Evaluating Associated Antithrombotic Treatments(1 year of follow up)
- Description of the population and centers(At inclusion)