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Suspended

NCT Number: NCT06168942

A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination

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).

Why the study stopped: Potential unwrapping of the LAA post implant with clinically significant leaks.
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Key information

Conditions

Non-valvular Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Systemic Embolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grandview Medical Center, Birmingham, Alabama, United States

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About this study

This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Experimental: Laminar Left Atrial Appendage Closure System

Device

Treatment with the Laminar Left Atrial Appendage Closure System.

Active Comparator: WATCHMAN / Amulet

Device

Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.

Primary outcomes

  1. All-Cause Mortality

    Time frame: Up to 12 months

    Composite rate of all-cause mortality will be reported.

  2. Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V

    Time frame: Up to 12 months

    The number of participants with major bleeding, according to the BARC type III or V, will be reported.

    Type III

    • Type IIIa includes overt bleeding plus a hemoglobin drop of 3 to less than (<) 5 grams per deciliter (g/dL) related to bleeding and any transfusion with overt bleeding.
    • Type IIIb involves overt bleeding plus a hemoglobin drop of greater than or equal to (>=) 5 g/dL related to bleeding, cardiac tamponade, bleeding requiring surgical intervention for control, or bleeding requiring intravenous vasoactive agents.
    • Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision.

    Type V

    • Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.
    • Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.

  3. Number of Participants With Pericardial Effusion Requiring Drainage

    Time frame: Up to 12 months

    Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death.

  4. Number of Participants With Device Embolization

    Time frame: Up to 12 months

    Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.

  5. Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention

    Time frame: Up to 12 Months

    Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported.

  6. Number of Participants Reporting Ischemic Stroke or Systemic Embolism

    Time frame: Up to 18 Months

    Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation).

Secondary outcomes

  1. Number of Participants With Peri-Device Flow

    Time frame: Up to 12 Months

    Peri-Device flow is defined as >= 3 mm in width which communicates beyond the device into the body of the left atrial appendage) per transesophageal echocardiogram (TEE) evaluated by independent core laboratory.

  2. Rate of Device-Related Thrombosis

    Time frame: Up to 12 Months

    Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging.

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

LAM202403: Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2032
First posted
Dec 13, 2023
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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