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

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Conditions studied: Non-valvular Atrial Fibrillation, Stroke, Systemic Embolism

In brief

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).

Key facts

Study ID

NCT06168942

Run by

Biosense Webster, Inc.

People needed

1500

Starts

2024-02-19

Expected to finish

2032-02-29

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• OC Medical Center — Fountain Valley, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Stanford Health Care — Palo Alto, California, United States
• Univeristy of California Davis Health — Rancho Cordova, California, United States
• Scripps Health — San Diego, California, United States
• Providence Saint John's Health Center and the Pacific Heart Institute — Santa Monica, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• St Vincents Medical Center 1 — Jacksonville, Florida, United States
• NCH Healthcare — North Naples, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• The Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Ascension via Christi Hospitals Wichita Inc — Wichita, Kansas, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Englewood Health — Englewood, New Jersey, United States
• Northwell Health — Bay Shore, New York, United States
• NYU Langone Health — New York, New York, United States
• Grandview Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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