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NCT05963698 · ClinicalTrials.gov registry record · NA
The Fourth Left Atrial Appendage Occlusion Study
A NA study of Atrial Fibrillation and Stroke, Ischemic, sponsored by Hamilton Health Sciences Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 4,000
- Enrollment target
- 20
- Study locations
NCT05963698: Recruiting NA study of Atrial Fibrillation and Stroke, Ischemic, sponsored by Hamilton Health Sciences Corporation.
NCT05963698 is a NA study of Atrial Fibrillation and Stroke, Ischemic that is actively recruiting participants, run by Hamilton Health Sciences Corporation. The registered enrollment target is 4,000 participants, above the 2,977-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05963698, a NA study of Atrial Fibrillation and Stroke, Ischemic, is actively recruiting participants, sponsored by Hamilton Health Sciences Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 4,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Primary Outcome
The primary efficacy variable is the time from randomization to first occurrence of any of the components of the composite outcome (adjudicated) over the duration of follow-up, including: * Ischemic stroke (Strokes of undetermined etiology will be treated as ischemic stroke) * Systemic embolism
Conditions Studied
Interventions
- DEVICE WATCHMAN device
Study Locations (20)
California
- Memorial Health Services - Fountain Valley
- Loma Linda University Health - Loma Linda
- Southern California Permanente Medical Group - Pasadena
- Sutter Valley Hospitals dba Sutter Institute for Medical Research - Sacramento
Florida
- JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital - Atlantis
- St. Vincent's Health System - Jacksonville
- Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center - Largo
- The University of South Florida - Tampa
Idaho
- St Luke's Regional Medical Center, Ltd - Boise
- Kootenai Health Inc. - Coeur d'Alene
Illinois
- Northwestern University - Evanston
- Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island - Rock Island
Alabama
- Affinity Hospital dba Grandview Medical Center - Birmingham
Arkansas
- Arrhythmia Research Group - Jonesboro
Georgia
- Emory University - Atlanta
Indiana
- Community Health Network Inc. - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,000 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2029-12-01 |
| Phase | NA |
What NCT05963698 shows while recruiting
NCT05963698 is an interventional study that assigns participants to a tested intervention. Its 4,000 participants enrollment target places it among the larger protocols in the corpus, above the 2,977-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (34% higher).
The record links to 3 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which WATCHMAN device is the first listed.
NCT05963698 names 20 study sites across 12 states, led by California, Florida, Idaho.
Frequently Asked Questions
What is clinical trial NCT05963698 about?
NCT05963698 is a clinical study titled "The Fourth Left Atrial Appendage Occlusion Study". LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
What is the current status of trial NCT05963698?
This trial is currently recruiting. It is a NA study. The enrollment target is 4,000 participants. The study started on 2023-11-30. Estimated completion is 2029-12-01.
What conditions does trial NCT05963698 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Stroke, Ischemic, Systemic Embolism.
What interventions are being tested in trial NCT05963698?
The interventions under investigation include: WATCHMAN device (DEVICE).
Who is sponsoring clinical trial NCT05963698?
This trial is sponsored by Hamilton Health Sciences Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05963698 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05963698's enrollment target sits among peer trials
4,000 18th of 202 higher than 184 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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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