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Comparing a new device for closing the left atrial appendage in patients with atrial fibrillation

Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study

Not applicable Interventional Biosense Webster, Inc. · NCT06168942

This study is testing a new device to see if it works better than current options for closing a part of the heart in patients with atrial fibrillation who want to lower their stroke risk without taking blood thinners.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1900 (estimated)
Ages18 Years and up
SexAll
SponsorBiosense Webster, Inc. Industry-sponsored
Locations65 sites (Birmingham, Alabama and 64 other locations)
Trial IDNCT06168942 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure (LAAC) device compared to existing commercially available devices in patients with non-valvular atrial fibrillation. Participants will be randomly assigned to receive either the experimental Laminar device or a standard device like WATCHMAN or Amulet. The study focuses on individuals who are eligible for short-term anticoagulation therapy but prefer a non-pharmacologic alternative to reduce their risk of stroke and systemic embolism. It is a multicenter, open-label study designed to gather comprehensive data on the outcomes of both devices.

Who should consider this trial

Good fit: Ideal candidates include individuals with documented non-valvular atrial fibrillation and a CHA2DS2-VASc score indicating a higher risk for stroke who are seeking alternatives to anticoagulation therapy.

Not a fit: Patients with transient or reversible atrial fibrillation or those not indicated for left atrial appendage closure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective non-pharmacologic option for patients with atrial fibrillation to reduce their risk of stroke.

How similar studies have performed: Other studies have shown success with similar left atrial appendage closure devices, indicating a promising avenue for this investigational approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
* CHA2DS2-VASc score greater than or equal to (\>=) 2 in men and \>= 3 in women
* Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
* Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
* Eligible for the protocol-specified post-procedural antithrombotic regimen
* Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements

Exclusion Criteria:

* Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
* Prior cardiac surgery or any procedure that involved pericardial access
* Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliters per minute per (mL/min)/1.73 square meters (m\^2) or participants with end stage renal disease who are dialysis dependent
* Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
* Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)

Where this trial is running

Birmingham, Alabama and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-valvular Atrial FibrillationStrokeSystemic Embolism
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.