Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

Brief description of study

Atrial fibrillation can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy.The purpose of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to OAC following atrial fibrillation ablation. This study involves an investigational device called the WATCHMAN FLXTM (the “Device”) which is permanently implanted in the LAA of your heart to close it off. The study will research the safety of the WATCHMAN FLX device and determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA following catheter ablation. The implantation of the WATCHMAN FLX Device is investigational. In other words, the WATCHMAN FLX Device has not been approved by the Food and Drug Administration (FDA).

Clinical Study Identifier: s19-00796 Identifier: NCT03795298
Principal Investigator: Larry A Chinitz.

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