Non-valvular Atrial Fibrillation, Stroke, Systemic Embolism
Conditions
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).
Detailed description
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).
Interventions
DEVICEExperimental: Laminar Left Atrial Appendage Closure System
Treatment with the Laminar Left Atrial Appendage Closure System.
DEVICEActive Comparator: WATCHMAN / Amulet
Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | Up to 12 months | Composite rate of all-cause mortality will be reported. |
| Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V | Up to 12 months | 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. |
| Number of Participants With Pericardial Effusion Requiring Drainage | 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. |
| Number of Participants With Device Embolization | 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. |
| Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention | Up to 12 Months | Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported. |
| Number of Participants Reporting Ischemic Stroke or Systemic Embolism | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Peri-Device Flow | 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. |
| Rate of Device-Related Thrombosis | Up to 12 Months | Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSaibal Kar, MD
Los Robles Health System
PRINCIPAL_INVESTIGATORDevi Nair, MD
St. Bernards Heart and Vascular Center
Outcome results
None listed