Left Atrial Appendage Closure Devices for Atrial Fibrillation

Not currently recruiting at 89 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Laminar Left Atrial Appendage Closure System, to evaluate its safety and effectiveness compared to existing devices for people with non-valvular atrial fibrillation (a type of irregular heartbeat) in reducing stroke and blood vessel blockages. Participants will receive either the Laminar device or a standard device already available on the market. The trial seeks individuals with ongoing issues related to this irregular heartbeat who are interested in alternatives to blood-thinning medications. As an unphased trial, it offers participants the chance to explore innovative treatment options beyond current standards.

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 prior data suggests that these left atrial appendage closure devices are safe for atrial fibrillation?

Research has shown that the Laminar Left Atrial Appendage Closure (LAAC) device appears safe. Early results from studies with animals and people with non-valvular atrial fibrillation suggest that the device is generally well-tolerated. These studies have not identified any major safety concerns. While this is promising, more research is underway to confirm these early findings. Participants should always discuss potential risks and benefits with healthcare professionals before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Laminar Left Atrial Appendage Closure System is unique because it offers an innovative approach to reducing stroke risk in patients with atrial fibrillation. Unlike standard devices, the Laminar system may provide improved sealing and reduced complication rates due to its advanced design. Researchers are excited because this system could enhance patient outcomes by minimizing the need for long-term blood thinners, which are commonly used with other devices but can cause side effects. This could make the Laminar system a safer and more effective option for patients.

What evidence suggests that the Laminar Left Atrial Appendage Closure System is effective for reducing stroke risk in atrial fibrillation?

Research has shown that the Laminar Left Atrial Appendage Closure (LAAC) System, which participants in this trial may receive, may help treat non-valvular atrial fibrillation, a type of irregular heartbeat. Studies have found that this device can lower the risk of stroke and blockages in blood vessels, which can damage important organs. Early results from both animal and human studies suggest it is safe and effective. The device closes a small pouch in the heart where clots often form, potentially preventing strokes in people with atrial fibrillation. ^{1 3 4 5 6}

Who Is on the Research Team?

Saibal Kar, MD

Principal Investigator

Los Robles Health System

Devi Nair, MD

Principal Investigator

St. Bernards Heart and Vascular Center

Are You a Good Fit for This Trial?

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

Current participation in another investigational drug or device study that in the opinion of the investigator could confound the data interpretation

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05565599

NCT05565599 | An Early Feasibility Study Evaluating the ... The objective of this study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular ...

2. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2023.04.028

Transcatheter Left Atrial Appendage Exclusion: Preclinical ... This study evaluates the safety and efficacy of the Laminar LAA exclusion device in healthy animals and human subjects with nonvalvular atrial fibrillation at ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1936879823007628

Transcatheter Left Atrial Appendage Exclusion: Preclinical ... This study evaluates the safety and efficacy of the Laminar LAA exclusion device in healthy animals and human subjects with nonvalvular atrial ...

4. jnj.com jnj.com/media-center/press-releases/biosense-webster-begins-enrollment-of-pivotal-trial-evaluating-the-laminar-left-atrial-appendage-elimination-device

Biosense Webster Begins Enrollment of Pivotal Trial ... The study will compare the safety and efficacy of the Laminar LAAX System to commercially available left atrial appendage (LAA) closure devices.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06168942

A Pivotal Investigational Device Exemption Study on ... 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37294221/

Transcatheter Exclusion of the Left Atrial Appendage Conclusions: The preclinical and early clinical results demonstrate a promising safety and efficacy profile for the Laminar LAA exclusion device ...