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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
Treatment with the Laminar Left Atrial Appendage Closure System.
Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.
All-Cause Mortality
Composite rate of all-cause mortality will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Grandview Medical Center
Birmingham, Alabama, United States
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
...and 60 more locations
Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported.
Time frame: 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).
Time frame: Up to 18 Months
Number of Participants With Peri-Device Flow
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.
Time frame: Up to 12 Months
Rate of Device-Related Thrombosis
Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging.
Time frame: Up to 12 Months