Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial (LeAAPS)

AtriCure

Status: Enrolling

Conditions: Ischemic Stroke; Systemic Embolism

Treatments: Device: AtriClip LAA Exclusion System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05478304

CP-2021-05

Details and patient eligibility

About

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.

Enrollment: 6,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6,500 participants in 2 patient groups

Treatment

Experimental group

Description:

LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery

Treatment:

Device: AtriClip LAA Exclusion System

Control

No Intervention group

Description:

No LAAE concomitant to and at the time of planned cardiac surgery