Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Description

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.

Conditions

Ischemic Stroke, Systemic Embolism

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Study Overview

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Study Details

Study overview

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.

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Condition
Ischemic Stroke
Intervention / Treatment

-

Contacts and Locations

Huntsville

Heart Center Research / Huntsville Hospital, Huntsville, Alabama, United States, 35801

Scottsdale

HonorHealth Shea Scottsdale Healthcare, Scottsdale, Arizona, United States, 85258

Jonesboro

St. Bernard's Heart & Vascular, Jonesboro, Arkansas, United States, 72401

Little Rock

CHI St. Vincent, Little Rock, Arkansas, United States, 72205

Little Rock

Arkansas Heart Hospital, Little Rock, Arkansas, United States, 72211

Long Beach

Memorial Care Long Beach Medical Center, Long Beach, California, United States, 90806

Los Angeles

Keck Medical Center of USC, Los Angeles, California, United States, 90033

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663

Sacramento

Sutter Sacramento Hospital, Sacramento, California, United States, 95816

Stanford

Stanford University, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AtriCure, Inc.,

Richard Whitlock, MD, STUDY_CHAIR, McMaster University

Study Record Dates

2032-04