Left Atrial Appendage Ligation Using the Atriclip Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Left Atrial Appendage Ligation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Left Atrial Appendage Ligation Atriclip atrial fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exclusion 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gansevoort Dunnington, MD

Role: PRINCIPAL_INVESTIGATOR

St. Helena Hospital Adventist Heart Institute

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

005

Identifier Type: -

Identifier Source: org_study_id