Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Not Applicable

Recruiting

• Conditions: Ischemic Stroke; Systemic Embolism

• Registration Number: NCT05478304
• Lead Sponsor: AtriCure, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-28
• Study Start: 2023-01-25
• Status Verified: 2024-10
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2031-12
• Study Completion: 2032-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Powered Secondary Effectiveness endpoint	Common termination point (median follow-up for 5 years)	Time to the first occurrence of ischemic stroke or systemic arterial embolism

Trial Locations

Locations (142)

Heart Center Research / Huntsville Hospital; 🇺🇸 Huntsville, Alabama, United States

HonorHealth Shea Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

St. Bernard's Heart & Vascular; 🇺🇸 Jonesboro, Arkansas, United States

CHI St. Vincent; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Heart Hospital; 🇺🇸 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

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Sutter Sacramento Hospital; 🇺🇸 Sacramento, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

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