Left Atrial Appendage Closure for Atrial Fibrillation

Recruiting at 6 trial locations

Overseen By Bryan Petrisko, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laminar, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Stroke, Renal insufficiency, Infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure day

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

Research on similar treatments, like the LAmbre closure system, shows that closing the left atrial appendage (a small pouch in the heart) can help prevent strokes in people with atrial fibrillation (a heart rhythm disorder). These treatments are often considered a good alternative to blood-thinning medications for some patients. ^{1 2 3 4 5}

Is left atrial appendage closure generally safe for humans?

Left atrial appendage closure has 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 with the procedure, and safety data often comes from specialized centers, which may not reflect typical clinical practice. ^{1 5 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 a unique treatment for atrial fibrillation as it offers a non-drug alternative to prevent stroke by physically closing off the left atrial appendage, which is a common source of blood clots in these patients. This approach is particularly beneficial for patients who cannot take long-term blood thinners due to other health issues. ^{5 9 10 11 12}

What is the purpose of this trial?

This is an early feasibility study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation that cannot take, or a have a reason to seek an alternative, to anticoagulant medications.

Eligibility Criteria

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

My stroke risk score is 2 or more if I'm a man, and 3 or more if I'm a woman.

I have a type of irregular heartbeat not caused by a heart valve issue.

Subject or Legally Authorized Representative informed of the nature of the study, is willing and able to comply with the protocol, and has provided written informed consent per Institutional Review Board (IRB) requirements

Exclusion Criteria

I have not had an AF ablation in the last 90 days but may need one soon.

I am not allergic to aspirin, heparin, nickel, or titanium.

I am not pregnant or nursing and do not plan to become pregnant within a year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

5 years

Regular visits as per study protocol

Treatment Details

Interventions

• Laminar Left Atrial Appendage Closure System

Trial Overview The trial tests the Laminar Left Atrial Appendage Closure System's safety and effectiveness in patients with atrial fibrillation who cannot take anticoagulants. It aims to provide a non-drug option for preventing strokes by sealing off a part of the heart where blood clots tend to form.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure system.

Who Is Running the Clinical Trial?

Laminar, Inc.

Lead Sponsor

Trials

4

Recruited

1,600+

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. 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]

4. 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]

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

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

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

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

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

Utilization and adverse outcomes of percutaneous left atrial appendage closure for stroke prevention in atrial fibrillation in the United States: influence of hospital volume. [2022]

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

Left atrial appendage closure followed by 6 weeks of antithrombotic therapy: a prospective single-center experience. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Transcatheter embolic coils to treat peridevice leaks after left atrial appendage closure. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

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