Left Atrial Appendage Ligation Using the Atriclip Device

Left Atrial Appendage Ligation Using the Atriclip Device; Single Center Study of Device Safety and Efficacy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03759418

Enrollment

100

Registered

2018-11-30

Start date

2016-04-30

Completion date

2018-04-30

Last updated

2018-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Atrial Appendage Ligation

Keywords

Left Atrial Appendage Ligation, Atriclip, atrial fibrillation

Brief summary

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.

Detailed 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.

Interventions

DEVICEexclusion of the left atrial appendage

A trans esophageal echocardiogram will be performed to assess the Atriclip device in the closure of the left atrial appendage in patients that had surgery at least 12 months ago.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
12 month follow up with complete exclusion of the Left Atrial Appendage	365 days to complete	The complete exclusion is defined by the lack of fluid communication between the left atrium and left atrial appendage at \</= 12 months

Secondary

Measure	Time frame	Description
Any signs of thrombus in the left atrium	365 days to compete	Any signs of thrombus in the left atrium
Occurrence of Cerebrovascular accident/transient Ischemic Attack	365 days to complete	Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026