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OpenTrials
Completed

NCT Number: NCT03759418

Left Atrial Appendage Ligation Using the Atriclip Device

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exclusion of the left atrial appendage

Device

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.

Primary outcomes

  1. 12 month follow up with complete exclusion of the Left Atrial Appendage

    Time frame: 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 outcomes

  1. Any signs of thrombus in the left atrium

    Time frame: 365 days to compete

    Any signs of thrombus in the left atrium

  2. Occurrence of Cerebrovascular accident/transient Ischemic Attack

    Time frame: 365 days to complete

    Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months

Sponsors and collaborators

Lead sponsor

St. Helena Hospital Coon Joint Replacement Institute

Other

Collaborators

  • Adventist Heart and Vascular Institute
  • AtriCure, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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