Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gabor Bagameri, M.D.

Open for enrollment

Contact information:

Lukman Tata M.S.

(507) 255-4158

Tata.Lukman@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20544193

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