NCT03434015

Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )

Post-approval Study of Percutaneous Left Atrial Appendage Closure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,051 (actual)
• Sponsor: French Cardiology Society · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2018-07-09
• Primary completion: 2020-02-15
• Completion: 2021-10-07
• First posted: 2018-02-15
• Last updated: 2022-09-16

Locations

1 site across 1 country: France