Left Atrial Appendage Closure for Atrial Fibrillation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new device called the Laminar Left Atrial Appendage Closure System. The goal is to determine its safety and effectiveness for individuals with non-valvular atrial fibrillation (a heart rhythm disorder) who cannot take blood thinners or need an alternative. It suits those advised to take blood thinners but cannot due to other health reasons. Participants should have ongoing atrial fibrillation issues and seek an alternative solution. As an unphased trial, this study provides participants the opportunity to explore a new treatment option that could potentially enhance their quality of life.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it is designed for people who cannot take or need an alternative to anticoagulant medications, so you might need to stop those if you are currently on them.
What prior data suggests that the Laminar Left Atrial Appendage Closure System is safe for patients with non-valvular atrial fibrillation?
Research shows that the Laminar Left Atrial Appendage Closure System has undergone safety testing in both animals and people with non-valvular atrial fibrillation. In these studies, the device appears promising, with no major safety issues reported so far. However, this is an early feasibility study, indicating that the treatment is still in the initial stages of human testing. Researchers are closely monitoring its safety to ensure it is well-tolerated by patients. As trials progress, more information will become available to better understand its safety.12345
Why are researchers excited about this trial?
The Laminar Left Atrial Appendage Closure System is unique because it offers a new approach to managing atrial fibrillation by physically closing off the left atrial appendage. Unlike traditional treatments that rely on blood thinners to reduce stroke risk, this device directly targets the source of clot formation by sealing it off. This reduces the need for long-term medication and its associated risks. Researchers are excited about its potential to offer a more permanent and less medication-dependent solution for patients with atrial fibrillation.
What evidence suggests that the Laminar Left Atrial Appendage Closure System is effective for non-valvular atrial fibrillation?
Research shows that the Laminar Left Atrial Appendage Closure System, which participants in this trial will receive, might help people with non-valvular atrial fibrillation, a type of irregular heartbeat. Early studies in animals and humans indicate that it can safely close the left atrial appendage, a part of the heart linked to blood clots in people with this condition. Blocking it might lower the risk of clots without needing blood-thinning medications. Other studies have compared this system to existing devices and suggest it may work just as well. However, more research is needed to confirm these findings in a larger group of people.12346
Are You a Good Fit for This Trial?
This study is for adults with non-valvular atrial fibrillation who need an alternative to blood thinners. Candidates should have a CHA2DS2-VASc score of at least 2 (men) or 3 (women), be able to follow the study plan, and consent to participate. People can't join if they've had only one AF episode, severe heart issues, recent major health events like stroke or infection, are pregnant/nursing, or have conditions that prevent proper testing or use of the device.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Laminar Left Atrial Appendage Closure System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biosense Webster, Inc.
Lead Sponsor
Dr. Nick West
Biosense Webster, Inc.
Chief Medical Officer
MD from Harvard Medical School
Jasmina Brooks
Biosense Webster, Inc.
Chief Executive Officer since 2023
Bachelor of Science in Biomedical Engineering from Louisiana Tech University
Laminar, Inc.
Lead Sponsor