AtriClip LAA Exclusion System: LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Study summary
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subjects ≥ 18 years of age
* Documentation of any of the following clinical criteria:
* CHA2DS2-VASc ≥ 4 with age ≥ 65
* CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
* CHA2DS2-VASc = 3 with age ≥ 75
* CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
* CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP
Exclusion Criteria:
* Clinically significant atrial fibrillation or atrial flutter:
* Anytime in the past and
* Documented by an electrocardiographic recording and
* Episode lasting 6 minutes or longer1\*
* Prior procedure involving opening the pericardium or entering the pericardial space
* Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
* Planned cardiac surgical procedure using non-sternotomy approaches
o Partial sternotomies will be allowed.
* Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
* Active endocarditis
* Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
* Known allergy to Nitinol or nickel sensitivity
* Known medical condition with expected survival of less than 1 year
* Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
* Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
* Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
* Pregnancy
* Known severe symptomatic carotid disease
Primary outcome measure(s)
Primary Effectiveness Endpoint — Common termination point (median follow-up for 5 years) Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.
Primary Safety Endpoint — 30 days post index procedure Occurrence of at least one of the following events assessed through 30 days post index procedure:
* Pericardial effusion requiring percutaneous or surgical treatment
* Major bleeding attributable to index surgical procedure
* Deep sternal wound infection
* Myocardial infarction
Trial sites (138)
Facility
City
Region
Status
Heart Center Research / Huntsville Hospital
Huntsville
Alabama
HonorHealth Shea Scottsdale Healthcare
Scottsdale
Arizona
St. Bernard's Heart & Vascular
Jonesboro
Arkansas
CHI St. Vincent
Little Rock
Arkansas
Arkansas Heart Hospital
Little Rock
Arkansas
Memorial Care Long Beach Medical Center
Long Beach
California
Keck Medical Center of USC
Los Angeles
California
Hoag Memorial Hospital Presbyterian
Newport Beach
California
Sutter Sacramento Hospital
Sacramento
California
Stanford University
Stanford
California
University of Colorado
Boulder
Colorado
Hartford Hospital
Hartford
Connecticut
Christiana Care Health Services
Newark
Delaware
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
HCA Florida JFK Hospital
Atlantis
Florida
HealthPark Medical Center
Fort Myers
Florida
University of Florida Hospital
Gainesville
Florida
Memorial Regional Hospital
Hollywood
Florida
Baptist Health Jacksonville
Jacksonville
Florida
Baptist Health South Florida
Miami
Florida
Orlando Regional Medical Center
Orlando
Florida
Sarasota Memorial Hospital
Sarasota
Florida
Tampa General Hospital
Tampa
Florida
Baycare Health System
Tampa
Florida
Emory University Hospital
Atlanta
Georgia
Piedmont Hospital
Atlanta
Georgia
Wellstar - Kennestone
Marietta
Georgia
St. Luke's Regional Medical Center
Boise
Idaho
Portneuf Medical Center
Idaho Falls
Idaho
Northwestern Memorial Hospital
Chicago
Illinois
Loyola University Medical Center
Maywood
Illinois
Memorial Hospital (SIU Medicine)
Springfield
Illinois
Ascension St. Vincent
Carmel
Indiana
Franciscan
Indianapolis
Indiana
Mercy Medical Center
Des Moines
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Iowa
St. Luke's Hospital
Kansas City
Kansas
Kansas University Medical Center
Kansas City
Kansas
Baptist Health
Lexington
Kentucky
University of Kentucky
Lexington
Kentucky
+ 98 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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