What is the Purpose of this Study?
The purpose of this study is to compare the safety and effectiveness of an experimental device called the Laminar Left Atrial Appendage Closure System with a commercially available left atrial appendage closure device that is used to close off the left atrial appendage to eliminate a potential source of blood clots. The study focuses on people who have atrial fibrillation, a condition in which the heart beats with an irregular rhythm. This irregular rhythm increases the chance of blood pooling and clotting inside the heart; the blood clots can break loose from the heart and cause a stroke.
Previous research has shown that closing the heart outpouching (left atrial appendage) eliminates the area where blood clots can form, ultimately lowering the chance of a stroke occurring. Closing the left atrial appendage using the Laminar investigational device or a commercially approved device is the main procedure of the study. Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the Laminar Left Atrial Appendage Closure Device, and Group 2 will receive a commercially available left atrial appendage closure device.
Eligibility
- * 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
Show more
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)
Show less
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Laminar Left Atrial Appendage Elimination Pivotal IDE Study