Left Atrial Appendage Ligation Using the Atriclip Device

NCT03759418 | Completed

• 1 other identifier: 005
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Left Atrial Appendage Ligation

Keywords

Left Atrial Appendage Ligation; Atriclip; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

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

  The complete exclusion is defined by the lack of fluid communication between the left atrium and left atrial appendage at \</= 12 months

  365 days to complete

Secondary Outcomes (2)

• Any signs of thrombus in the left atrium

  365 days to compete

• Occurrence of Cerebrovascular accident/transient Ischemic Attack

  365 days to complete

Interventions

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients who had an Atriclip placed to exclude the left atrial appendage.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Helena Hospital Coon Joint Replacement Institute: lead
• AtriCure, Inc.: collaborator
• Adventist Heart and Vascular Institute: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gansevoort Dunnington, MD

  St. Helena Hospital Adventist Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: November 30, 2018
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share