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

Study Overview
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Brief Summary
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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.

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

Conditions
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Left Atrial Appendage Occlusion

Intervention / Treatment
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* Device: intra-procedural intracardiac echocardiography (ICE) probe


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE)<br>100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. | Device: intra-procedural intracardiac echocardiography (ICE) probe<br>* placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implantation of WATCHMAN FLX device | Number of successfully implanted WACHMAN FLX devices. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant. | 45 days post procedure | 
| Major complications | Number of major complications as defined as major bleeding (intracranial bleeding, or bleeding requiring blood transfusion), pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death). | 45 days post procedure |