Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING NA

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

NCT05478304 · View on ClinicalTrials.gov ↗

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.

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

13 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,573 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AtriCure, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05478304 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05478304?

The interventions under investigation include: AtriClip LAA Exclusion System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05478304?

This trial is sponsored by AtriCure, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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