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

NCT06168942 | Suspended DMC FDA Device

• 2 other identifiers: LAM202403CL-0059
• Study Type: interventional
• Target: 1,500
• Locations: 11 countries
• Sites: 71

Brief Summary

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).

Conditions

Non-valvular Atrial Fibrillation; Stroke; Systemic Embolism

Outcome Measures

Primary Outcomes (6)

• All-Cause Mortality

  Composite rate of all-cause mortality will be reported.

  Up to 12 months

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

  The number of participants with major bleeding, according to the BARC type III or V, will be reported. Type III 1. 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. 2. 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. 3. Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision. Type V 1. Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious. 2. Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.

  Up to 12 months

• Number of Participants With Pericardial Effusion Requiring Drainage

  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.

  Up to 12 months

• Number of Participants With Device Embolization

  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.

  Up to 12 months

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

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

  Up to 12 Months

• Number of Participants Reporting Ischemic Stroke or Systemic Embolism

  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).

  Up to 18 Months

Secondary Outcomes (2)

• Number of Participants With Peri-Device Flow

  Up to 12 Months

• Rate of Device-Related Thrombosis

  Up to 12 Months

Study Arms (2)

Laminar Device

EXPERIMENTAL

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

Device: Experimental: Laminar Left Atrial Appendage Closure System

Control left atrial appendage closure (LAAC)

ACTIVE COMPARATOR

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

Device: Active Comparator: WATCHMAN / Amulet

Interventions

Active Comparator: WATCHMAN / Amulet DEVICE

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

Control left atrial appendage closure (LAAC)

Experimental: Laminar Left Atrial Appendage Closure System DEVICE

Treatment with the Laminar Left Atrial Appendage Closure System.

Laminar Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (71)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG

Phoenix, Arizona, 85018, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

OC Medical Center

Fountain Valley, California, 92708, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford Health Care

Palo Alto, California, 94303, United States

Location

Univeristy of California Davis Health

Rancho Cordova, California, 95670, United States

Location

Scripps Health

San Diego, California, 92121, United States

Location

Providence Saint John's Health Center and the Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

St Vincents Medical Center 1

Jacksonville, Florida, 32204, United States

Location

NCH Healthcare

North Naples, Florida, 34102, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Ascension via Christi Hospitals Wichita Inc

Wichita, Kansas, 67214, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Englewood Health

Englewood, New Jersey, 07631, United States

Location

Northwell Health

Bay Shore, New York, 11706, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University in the City of New York and The New York and Presbyterian Hospital

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Wake Forest University Health Sciences

Charlotte, North Carolina, 28203, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Bethesda North Hospital Trihealth

Cincinnati, Ohio, 45202, United States

Location

Lindner Clinical Trial Center/Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Ohio Health

Columbus, Ohio, 43214, United States

Location

Trident Medical Center

North Charleston, South Carolina, 29406, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Heart Rhythm Associates

Shenandoah, Texas, 77380, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

St Joseph Hospital and Medical Center

Tacoma, Washington, 98405, United States

Location

Mercy Hospital

Janesville, Wisconsin, 53548, United States

Location

AZORG campus Aalst Moorselbaan

Aalst, 9300, Belgium

Location

AZ Sint Jan Brugge Oostende AV

Bruges, 8000, Belgium

Location

C.H.U. Brugmann

Brussels, 1020, Belgium

Location

CHU Charleroi Chimay

Charleroi, 6042, Belgium

Location

Nemocnice na Homolce

Prague, 150 30 District 5, Czechia

Location

Rigshospitalet Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Hopital Prive Jacques Cartier

Massy, 91300, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

MVZ CCB Frankfurt und Main Taunus GbR

Frankfurt a.M., 60431, Germany

Location

CVC CardioVascular Center Frankfurt

Frankfurt am Main, 60389, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 22587, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Fondazione Toscana Gabriele Monasterio CNR

Massa, 54100, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

Vilnius University Hospital Santaros Clinics

Vilnius, 08661, Lithuania

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 61 848, Poland

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36213, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Saibal Kar, MD

  Los Robles Health System

  PRINCIPAL INVESTIGATOR

• Devi Nair, MD

  St. Bernards Heart and Vascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: February 19, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 29, 2032
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); PL (1); BE (4); US (45); ES (6); LI (1); DK (1); FR (2); IT (4); NL (2); DE (4)