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NCT05478304 · ClinicalTrials.gov registry record · NA

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

A NA study of Ischemic Stroke and Systemic Embolism, sponsored by AtriCure.

Active
Registry status
NA
Development phase
6,573
Enrollment target
20
Study locations

NCT05478304 is a NA study of Ischemic Stroke and Systemic Embolism that is active but no longer recruiting, run by AtriCure. The registered enrollment target is 6,573 participants, above the 1,364-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (382% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT05478304, a NA study of Ischemic Stroke and Systemic Embolism, is active but no longer recruiting, sponsored by AtriCure.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
6,573 participants
Enrollment target
20
Study locations

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 Studied

Ischemic Stroke Systemic Embolism

Interventions

  • DEVICE AtriClip LAA Exclusion System

Study Locations (20)

Florida

  • HCA Florida JFK Hospital - Atlantis
  • HealthPark Medical Center - Fort Myers
  • University of Florida Hospital - Gainesville
  • Memorial Regional Hospital - Hollywood
  • Baptist Health Jacksonville - Jacksonville
  • Baptist Health South Florida - Miami

California

  • Memorial Care Long Beach Medical Center - Long Beach
  • Keck Medical Center of USC - Los Angeles
  • Hoag Memorial Hospital Presbyterian - Newport Beach
  • Sutter Sacramento Hospital - Sacramento
  • Stanford University - Stanford

Arkansas

  • St. Bernard's Heart & Vascular - Jonesboro
  • CHI St. Vincent - Little Rock
  • Arkansas Heart Hospital - Little Rock

Alabama

  • Heart Center Research / Huntsville Hospital - Huntsville

Arizona

  • HonorHealth Shea Scottsdale Healthcare - Scottsdale

Colorado

  • University of Colorado - Boulder

Connecticut

  • Hartford Hospital - Hartford

Delaware

  • Christiana Care Health Services - Newark

Trial Details

FieldValue
Enrollment Target 6,573 participants
Start Date 2023-01-25
Est. Completion 2032-04
Phase NA

Sponsor

AtriCure

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05478304

The ClinicalTrials.gov registry entry for NCT05478304 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 6,573 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,364-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (382% higher). The listed sponsor is AtriCure, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Ischemic Stroke appearing as the primary indexed condition, and to 1 intervention - of which AtriClip LAA Exclusion System is the first listed.

NCT05478304 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05478304 about?

NCT05478304 is a clinical study titled "Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial". 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 s...

What is the current status of trial NCT05478304?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 6,573 participants. The study started on 2023-01-25. Estimated completion is 2032-04.

What conditions does trial NCT05478304 study?

This clinical trial studies the following conditions: Ischemic Stroke, Systemic Embolism.

What interventions are being tested in trial NCT05478304?

The interventions under investigation include: AtriClip LAA Exclusion System (DEVICE).

Who is sponsoring clinical trial NCT05478304?

This trial is sponsored by AtriCure, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05478304 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.