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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: Active NA study of Ischemic Stroke and Systemic Embolism, sponsored by AtriCure.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 6,573 participants |
| Start Date | 2023-01-25 |
| Est. Completion | 2032-04 |
| Phase | NA |
What the registry record for NCT05478304 still lists
NCT05478304 is an interventional study that assigns participants to a tested intervention. Its 6,573 participants enrollment target places it among the larger protocols in the corpus, above the 1,364-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (382% higher).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT05478304's enrollment target sits among peer trials
6,573 3rd of 66 higher than 64 of 66 other Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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