ClinicalTrials.Veeva

Menu
The trial is taking place at:
M

Munson Medical Center | Cancer Research Department

Veeva-enabled site

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

AtriCure logo

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

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

Trial contacts and locations

102

Loading...

Central trial contact

Kirstin Smentek; LeAAPS inbox

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems