Left Atrial Appendage Closure Devices for Atrial Fibrillation

Recruiting at 77 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laminar, Inc.

Must be taking: Oral anticoagulants

Disqualifiers: Stage IV kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

1900 Participants Needed

Trial Summary

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 mentions that participants should be recommended for chronic oral anticoagulation therapy but have a reason to seek a non-drug alternative.

What data supports the effectiveness of the Laminar Left Atrial Appendage Closure System treatment for atrial fibrillation?

Research on similar left atrial appendage closure devices shows they can be effective alternatives to blood thinners for preventing strokes in people with atrial fibrillation, with high success rates and fewer complications during the procedure. ^{1 2 3 4 5}

Is the left atrial appendage closure device safe for humans?

Left atrial appendage closure devices have been studied for safety in patients with atrial fibrillation, showing an acceptable safety profile when combined with antiplatelet therapy. However, there is an initial risk associated with the procedure, and postapproval data is limited, so ongoing monitoring is important. ^{1 2 6 7 8}

How is the Laminar Left Atrial Appendage Closure System treatment different from other treatments for atrial fibrillation?

The Laminar Left Atrial Appendage Closure System is unique because it uses a rotating mechanism with an integrated ball and lock to close the left atrial appendage, minimizing the risk of leaks and blood clots compared to other devices. ^{9 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).

Research Team

Saibal Kar, MD

Principal Investigator

Los Robles Health System

Devi Nair, MD

Principal Investigator

St. Bernards Heart and Vascular Center

Eligibility Criteria

This trial is for adults over 18 with non-valvular atrial fibrillation at high stroke risk who need an alternative to long-term blood thinners. Candidates should be suitable for a specific post-procedure drug regimen and have a CHA2DS2-VASc score indicating moderate to high stroke risk.

Inclusion Criteria

My CHA2DS2-VASc score is 2 or more (if I am a man) or 3 or more (if I am a woman).

I have been approved for LAA closure by two doctors using a specific decision tool.

I need blood thinners but am looking for a non-drug option.

Exclusion Criteria

Left atrial appendage anatomy which cannot accommodate both commercially available control device and the Laminar Implant per manufacturer IFU

Presence of inferior vena cava (IVC) filter that would interfere with access

I am currently being treated for an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Laminar Left Atrial Appendage Closure System or a commercially available LAAC device

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for major bleeding, pericardial effusion, device embolization, and ischemic stroke or systemic embolism

Up to 18 months

Treatment Details

Interventions

• Laminar Left Atrial Appendage Closure System

Trial Overview The study compares the new Laminar Left Atrial Appendage Closure System with existing devices like WATCHMAN™/Amulet™ in preventing strokes in patients with atrial fibrillation. Participants are randomly assigned to one of the treatments.

Participant Groups

Group I: Laminar Device Experimental Treatment 1 Intervention

Participants will be treated with the Laminar Left Atrial Appendage Closure System.

Group II: Control left atrial appendage closure (LAAC) Active Control 1 Intervention

Participants will be treated with a commercially-available LAAC device.

Who Is Running the Clinical Trial?

Laminar, Inc.

Lead Sponsor

Trials

4

Recruited

1,600+

Biosense Webster, Inc.

Lead Sponsor

Trials

128

Recruited

37,100+

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

Cardiovascular Research Foundation, New York

Collaborator

Trials

28

Recruited

27,800+

Findings from Research

In a study of 140 patients with non-valvular atrial fibrillation, the LAmbre LAA occluder system demonstrated a 100% implant success rate, comparable to the Amulet and Watchman devices, indicating its effectiveness as an alternative to anticoagulation.

All three devices (LAmbre, Amulet, and Watchman) showed low rates of major peri-procedural adverse events and maintained good clinical outcomes at six months, suggesting they are safe options for left atrial appendage closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation. Chen, S., Chun, KRJ., Bordignon, S., et al.[2020]

Atrial fibrillation (AF) significantly increases the risk of blood clots, particularly in the left atrial appendage (LAA), which is a key area for thrombus formation in patients with non-valvular AF.

The review discusses the safety and efficacy of various LAA closure devices, including the WATCHMAN and Amplatzer devices, highlighting the need for further well-designed studies to compare these devices with new oral anticoagulant treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage isolation using percutaneous (endocardial/epicardial) devices: Pre-clinical and clinical experience. Romero, J., Natale, A., Engstrom, K., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adverse Events After Left Atrial Appendage Closure: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Database. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Left Atrial Appendage Closure With the LAmbre Device for Stroke Prevention in Atrial Fibrillation: A Prospective, Multicenter Clinical Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Procedural success and intra-hospital outcome related to left atrial appendage morphology in patients that receive an interventional left atrial appendage closure. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Thoracoscopic stapler-and-loop technique for left atrial appendage closure in nonvalvular atrial fibrillation: Mid-term outcomes in 201 patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical Results with Percutaneous Left Atrial Appendage Occlusion. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

A Review Of Clinical Trials On LARIAT Device. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Left Atrial Appendage Exclusion: Preclinical and Early Clinical Results With the Laminar Device. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure - new choice for no-option patients with atrial fibrillation. [2016]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Left atrial appendage isolation using percutaneous (endocardial/epicardial) devices: Pre-clinical and clinical experience. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Percutaneous Left Atrial Appendage Closure with the LAmbre Device. [2022]