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Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

NCT05478304•AtriCure, Inc.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (143)

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

Key Dates

Start Date

January 25, 2023

Primary Completion Date

December 1, 2031

Completion Date

April 1, 2032

Last Updated

August 12, 2025

Enrollment

6,573

ACTUAL participants

Conditions

Ischemic StrokeSystemic Embolism

Interventions

AtriClip LAA Exclusion System

DEVICE

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

NCT07371455

Ischemic Stroke

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RECRUITINGPHASE3

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

NCT07253181

Acute Ischemic StrokeLarge Vessel Occlusion+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Prospective Randomized Observer Blinded Single Center Study Comparing 90-day Functional Outcome in Patients Who Received Intravenous Propofol Infusion Versus Inhalational Sevoflurane for General Anesthesia During Mechanical Thrombectomy in Patients Who Suffered From Acute Ischemic Stroke

The Fourth Left Atrial Appendage Occlusion Study

18F FDG and 68Ga FAPI PET/MR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients