RecruitingNot ApplicableNCT06007872

Intracardiac Echocardiography Guided Watchman Device Implant

Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant

Sponsor

The Cleveland Clinic

Enrollment

100 participants

Start Date

Dec 2, 2022

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Left Atrial Appendage Thrombosis

Summary

This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial

Exclusion Criteria4

Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
Patients receiving a concomitant ablation procedure
Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).