← Back to all trials
Suspended
NCT06168942
A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
Conditions: Non-valvular Atrial Fibrillation, Stroke, Systemic Embolism
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1500
Sponsor: Biosense Webster, Inc.
Location: Grandview Medical Center Birmingham Alabama
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).
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 (\
Source: ClinicalTrials.gov (NCT06168942). StuddyBuddy aggregates publicly available trial information.