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Active, not recruiting Not applicable

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

NCT05478304 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-01-25
Last updated
2026-03-24

Condition(s) studied

Ischemic StrokeSystemic Embolism

Investigational drug(s) / intervention(s)

AtriClip LAA Exclusion System

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)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT05478304 on ClinicalTrials.gov ↗ ← All trials in Spain