Clinical trial NCT05478304: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Official title: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Systemic Embolism
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Population Health Research Institute
First posted: 2022-07-28
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: Common termination point (median follow-up for 5 years)
measure: Primary Safety Endpoint
timeFrame: 30 days post index procedure
Secondary outcomes:
measure: Powered Secondary Effectiveness endpoint
timeFrame: Common termination point (median follow-up for 5 years)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research / Huntsville Hospital
state: Alabama
city: Scottsdale
country: United States
facility: HonorHealth Shea Scottsdale Healthcare
state: Arizona
city: Jonesboro
country: United States
facility: St. Bernard's Heart & Vascular
state: Arkansas
city: Little Rock
country: United States
facility: CHI St. Vincent
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Long Beach
country: United States
facility: Memorial Care Long Beach Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Sacramento
country: United States
facility: Sutter Sacramento Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: HCA Florida JFK Hospital
state: Florida
city: Fort Myers
country: United States
facility: HealthPark Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Jacksonville
state: Florida
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Orlando
country: United States
facility: Advent South
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Baycare Health System
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Marietta
country: United States
facility: Wellstar - Kennestone
state: Georgia
city: Boise
country: United States
facility: St. Luke's Regional Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Portneuf Medical Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Memorial Hospital (SIU Medicine)
state: Illinois
city: Carmel
country: United States
facility: Ascension St. Vincent
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan
state: Indiana
city: Des Moines
country: United States
facility: Mercy Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Kansas
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Health / Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: Novant Presbyterian Hospital
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Hospital
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Royal Oak
country: United States
facility: Corewell Health East
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health (formerly St. Joesph Mercy)
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern / Minneapolis Heart
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Midwest Heart and Vascular (HCA)
state: Missouri
city: Saint Louis
country: United States
facility: St. Lukes Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist
state: Nebraska
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Woods Johnson Medical School
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital (Northwell)
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Syracuse
country: United States
facility: St. Joseph Hospital
state: New York
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth / Bethesda North Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Christ Hospital / Lindner Research Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Ohio State Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital (Promedica)
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Health System
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Jackson
country: United States
facility: Jackson Madison County General
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center (TriStar)
state: Tennessee
city: Nashville
country: United States
facility: Ascension St. Thomas West
state: Tennessee
city: Austin
country: United States
facility: UT Dell Medical School
state: Texas
city: Dallas
country: United States
facility: HCA Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Heart Hospital - Plano
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances (CHRISTUS)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Medical
state: Virginia
city: Norfolk
country: United States
facility: Sentara Hospitals & Sentara Medical Group
state: Virginia
city: Seattle
country: United States
facility: Swedish Heart and Vascular Research
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center (CAMC)
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Columbia St. Mary's
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Hospital
state: Wisconsin
city: Clayton
country: Australia
facility: Victorian Heart Hospital and Monash University
state: Victoria
city: Graz
country: Austria
facility: Medical University Hospital Graz
state: Styria
city: Vienna
country: Austria
facility: Medical University Vienna
city: Leuven
country: Belgium
facility: University Hospitals UZ Leuven
state: Brabant
city: Jette
country: Belgium
facility: UZ Brussels
state: Brussels
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Saint John
country: Canada
facility: New Brunswick Heart Centre
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II - Nova Scotia Health
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: IUCPQ Hosptial Laval
city: Brno
country: Czechia
facility: CKTCH Brno
city: Bad Neustadt An Der Saale
country: Germany
facility: Rhön-Klinikum Campus Bad Neustadt
state: Bavaria
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
state: Brandenburg
city: Bad Rothenfelde
country: Germany
facility: Bad Rothefelde Schüchtermann-Klinik
state: Lower Saxony
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
state: Great Britain
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
state: North Yorkshire
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
Study officials:
affiliation: McMaster University
name: Richard Whitlock, MD
role: STUDY_CHAIR
References: