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

Mayo Clinic100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Left Atrial Appendage Occlusion

Interventions

intra-procedural intracardiac echocardiography (ICE) probeDEVICE

placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Pacific Heart Institute

Santa Monica, California, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Successful Implantation of WATCHMAN FLX Device

Number of participants with a successfully implanted WATCHMAN FLX device. 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 transesophageal echocardiogram (TEE) 45 days post-implant.

Time frame: 45 days post procedure

Major Complications

Number of participants who experience major complications 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).

Time frame: up to 7 days post procedure

Secondary Outcomes

Procedure Conversion to General Anesthesia

Number of participants who required conversion from moderate sedation to general anesthesia for implant procedure.

Time frame: baseline

Iatrogenic Atrial Septal Defect

Number of participants with an iatrogenic atrial septal defect.

Time frame: 45 days post procedure

Data from ClinicalTrials.gov

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