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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
  • Device: AtriClip LAA Exclusion System
    LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
No Intervention
Control
No LAAE concomitant to and at the time of planned cardiac surgery

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Kerrie Brewer
859-240-8994
kerrie.brewer@uky.edu

More Details

NCT ID
NCT05478304
Status
Recruiting
Sponsor
AtriCure, Inc.

Study Contact

Kirstin Smentek
612.430.1398
ksmentek@atricure.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.