Left Atrial Appendage Ligation Using the Atriclip Device

St. Helena Hospital Coon Joint Replacement Institute

Status: Completed

Conditions: Left Atrial Appendage Ligation

Treatments: Device: exclusion of the left atrial appendage

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03759418

005

Details and patient eligibility

About

The purpose of the study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures.

Full description

The purpose of this study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures. The patient will undergo a transesophageal echocardiogram (TEE) to collect the following data: Left Ventricular Ejection Fraction; Left Atrial diameter size; confirmation of Left Atrial Appendage exclusion defined by the absence of left atrial to LAA (left atrial appendage) communication measured in millimeters and absence of LAA pocket measured in millimeters; presence of thrombus in left atrium.

Enrollment: 100 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patient who had a heart procedure where an Atriclip device was deployed as the primary or secondary procedure between 3/2013-12/20/2016
• Patient is willing to undergo a trans esophageal echocardiogram, or if unable a CT angiogram
• If female, must be of non-childbearing potential or have a negative pregnancy test within 7 days prior to the procedure
• Patient is willing to sign an IRB approved Informed Consent

Exclusion criteria

• Patient did not have an Atriclip device as part of the surgical procedure between 3/2013 and 12/2016.
• Patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a CT angiogram