Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
Overview
- Phase
- Not Applicable
- Intervention
- Experimental: Laminar Left Atrial Appendage Closure System
- Conditions
- Not specified
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 1500
- Locations
- 124
- Primary Endpoint
- All-Cause Mortality
- Status
- Suspended
- Last Updated
- 19 days ago
Overview
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).
Investigators
Eligibility Criteria
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)
Arms & Interventions
Laminar Device
Participants will be treated with the Laminar Left Atrial Appendage Closure System.
Intervention: Experimental: Laminar Left Atrial Appendage Closure System
Control left atrial appendage closure (LAAC)
Participants will be treated with a commercially-available LAAC device.
Intervention: Active Comparator: WATCHMAN / Amulet
Outcomes
Primary Outcomes
All-Cause Mortality
Time Frame: 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
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 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
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.
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.
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.
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
- Number of Participants With Peri-Device Flow(Up to 12 Months)
- Rate of Device-Related Thrombosis(Up to 12 Months)