Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Ischemic Stroke Clinical Trial

— LeAAPS  

Official title:

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478304
• Other study ID #: CP-2021-05
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: April 2032

Study information

• Verified date: May 2024
• Source: AtriCure, Inc.
• Contact: Kirstin Smentek
• Phone: 612.430.1398
• Email: ksmentek[@]atricure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6500
• Est. completion date: April 2032
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Ischemic Stroke
• Stroke
• Systemic Embolism

Intervention

Device:
• AtriClip LAA Exclusion System
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	IUCPQ / Hospital Laval	Québec
Canada	New Brunswick Heart Centre	Saint John	New Brunswick
Canada	St Michael's Hospital	Toronto	Ontario
United Kingdom	Northern General Hospital	Sheffield	Great Britain
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	UT Dell Medical School	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Ascension St. Vincent	Carmel	Indiana
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Christ Hospital / Lindner Research Center	Cincinnati	Ohio
United States	TriHealth / Bethesda North Hospital	Cincinnati	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Ohio State Medical Center	Columbus	Ohio
United States	Riverside Methodist	Columbus	Ohio
United States	Mercy Medical Center	Des Moines	Iowa
United States	Inova Fairfax Medical	Falls Church	Virginia
United States	HealthPark Medical Center	Fort Myers	Florida
United States	University of Florida Hospital	Gainesville	Florida
United States	Corewell Health	Grand Rapids	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	UPMC Pinnacle	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Heart Center Research / Huntsville Hospital	Huntsville	Alabama
United States	Portneuf Medical Center	Idaho Falls	Idaho
United States	Franciscan	Indianapolis	Indiana
United States	Jackson Madison County General	Jackson	Tennessee
United States	St. Bernard's Heart & Vascular	Jonesboro	Arkansas
United States	Midwest Heart and Vascular (HCA)	Kansas City	Missouri
United States	St. Luke's Hospital	Kansas City	Kansas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	CHI St. Vincent	Little Rock	Arkansas
United States	Memorial Care Long Beach Medical Center	Long Beach	California
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of Louisville Health / Jewish Hospital	Louisville	Kentucky
United States	North Shore University Hospital (Northwell)	Manhasset	New York
United States	Wellstar - Kennestone	Marietta	Georgia
United States	Loyola University Medical Center	Maywood	Illinois
United States	Baptist Health South Florida	Miami	Florida
United States	Columbia St. Mary's	Milwaukee	Wisconsin
United States	Abbott Northwestern / Minneapolis Heart	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Ascension St. Thomas West	Nashville	Tennessee
United States	Centennial Medical Center (TriStar)	Nashville	Tennessee
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Sentara Hospitals & Sentara Medical Group	Norfolk	Virginia
United States	Nebraska Methodist	Omaha	Nebraska
United States	The Nebraska Medical Center	Omaha	Nebraska
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Health System	Pittsburgh	Pennsylvania
United States	Baylor Heart Hospital - Plano	Plano	Texas
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Francis Hospital	Roslyn	New York
United States	St. Lukes Hospital	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	HonorHealth Shea Scottsdale Healthcare	Scottsdale	Arizona
United States	Swedish Heart and Vascular Research	Seattle	Washington
United States	Memorial Hospital (SIU Medicine)	Springfield	Illinois
United States	St. Joseph Hospital	Syracuse	New York
United States	Baycare Health System	Tampa	Florida
United States	The Toledo Hospital (Promedica)	Toledo	Ohio
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Trinity Mother Frances (CHRISTUS)	Tyler	Texas
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Hospital	Wausau	Wisconsin
United States	Novant Presbyterian Hospital	Winston-Salem	North Carolina
United States	Wake Forest Baptist	Winston-Salem	North Carolina
United States	Lankenau Hospital	Wynnewood	Pennsylvania
United States	Trinity Health (formerly St. Joesph Mercy)	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
AtriCure, Inc.	Population Health Research Institute

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	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.	Common termination point (median follow-up for 5 years)
Primary	Primary Safety Endpoint	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	30 days post index procedure
Secondary	Powered Secondary Effectiveness endpoint	Time to the first occurrence of ischemic stroke or systemic arterial embolism	Common termination point (median follow-up for 5 years)