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Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

NCT05478304 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6573

Last updated 2026-03-24

No results posted yet for this study

Summary

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

Interventions

DEVICE

AtriClip LAA Exclusion System

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

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • AtriCure, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Whitlock, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2031-12-31
Completion
2032-04-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Germany
  • New Zealand
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05478304 on ClinicalTrials.gov