Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device

Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study

The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.

Inclusion Criteria:

• The patients is eligible to undergo WATCHMAN device implant procedure.
• The patient is eligible for short term anticoagulation therapy.
• Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s).
• Ability to give informed consent for the procedure.
• The patient is able and willing to undergo the procedure under moderate sedation.
• The patient is able and willing to return for required 45-day transesophageal echocardiogram (TEE).

Exclusion Criteria:

• Patient has contraindication for short term anticoagulation.
• The patient has history of a hypercoagulable state per medical record documentation.
• Pregnancy or planning to get pregnant during the investigation.